Trial Outcomes & Findings for VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial (NCT NCT03820947)

Results Overview

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

506 participants

Primary outcome timeframe

30 days

Results posted on

2025-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Overall Study STARTED	136	139	53	53	125
Overall Study COMPLETED	115	104	43	39	87
Overall Study NOT COMPLETED	21	35	10	14	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Overall Study Lost to Follow-up	4	6	0	0	9
Overall Study Physician Decision	0	1	1	0	3
Overall Study Withdrawal by Subject	6	10	3	8	5
Overall Study Procedure Not Attempted	0	2	1	0	0
Overall Study Other Exit	1	3	3	3	0
Overall Study Follow-up Not Done	10	13	2	3	12
Overall Study Death	0	0	0	0	9

Baseline Characteristics

Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=136 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=139 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System n=125 Participants CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Total n=506 Participants Total of all reporting groups
Age, Continuous	57.0 years STANDARD_DEVIATION 13.20 • n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	57.2 years STANDARD_DEVIATION 13.70 • n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	60.3 years STANDARD_DEVIATION 14.39 • n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	61.5 years STANDARD_DEVIATION 12.96 • n=49 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	67.9 years STANDARD_DEVIATION 14.76 • n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	60.7 years STANDARD_DEVIATION 14.52 • n=485 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.
Sex/Gender, Customized Female	91 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	78 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	29 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	33 Participants n=49 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	48 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	279 Participants n=485 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.
Sex/Gender, Customized Male	40 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	52 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	21 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	16 Participants n=49 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	77 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	206 Participants n=485 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.
Race/Ethnicity, Customized Not reportable per local laws or regulations	67 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	69 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	7 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	4 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	55 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	202 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Subject declines to answer	0 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	3 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	3 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Unknown	0 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	3 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	3 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Black or African American	1 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	1 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	3 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	5 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Chinese	0 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Japanese	0 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Korean	13 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	14 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	38 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	41 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	106 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Native American or Alaska Native	0 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Native Hawaiian or Other Pacific islander	0 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	1 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	1 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized White	50 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	42 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	5 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	3 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	63 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	163 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Other Asian	0 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	1 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	1 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	2 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Race/Ethnicity, Customized Other	0 Participants n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=48 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.	0 Participants n=484 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure. Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.
Body Mass Index	26.4 kg/m2 STANDARD_DEVIATION 4.93 • n=131 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	27.9 kg/m2 STANDARD_DEVIATION 5.77 • n=130 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	25.8 kg/m2 STANDARD_DEVIATION 5.77 • n=50 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	24.2 kg/m2 STANDARD_DEVIATION 3.41 • n=47 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	32.4 kg/m2 STANDARD_DEVIATION 9.35 • n=125 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.	28.1 kg/m2 STANDARD_DEVIATION 7.08 • n=483 Participants • Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.
CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C0	0 Participants n=136 Participants	0 Participants n=139 Participants	0 Participants n=53 Participants	0 Participants n=53 Participants	0 Participants n=125 Participants	0 Participants n=506 Participants
CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C1	0 Participants n=136 Participants	0 Participants n=139 Participants	0 Participants n=53 Participants	0 Participants n=53 Participants	0 Participants n=125 Participants	0 Participants n=506 Participants
CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C2	43 Participants n=136 Participants	48 Participants n=139 Participants	22 Participants n=53 Participants	23 Participants n=53 Participants	0 Participants n=125 Participants	136 Participants n=506 Participants
CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C3	61 Participants n=136 Participants	53 Participants n=139 Participants	17 Participants n=53 Participants	18 Participants n=53 Participants	0 Participants n=125 Participants	149 Participants n=506 Participants
CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C4a	28 Participants n=136 Participants	25 Participants n=139 Participants	12 Participants n=53 Participants	9 Participants n=53 Participants	0 Participants n=125 Participants	74 Participants n=506 Participants
CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C4b	4 Participants n=136 Participants	4 Participants n=139 Participants	1 Participants n=53 Participants	2 Participants n=53 Participants	0 Participants n=125 Participants	11 Participants n=506 Participants
CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C5	0 Participants n=136 Participants	9 Participants n=139 Participants	1 Participants n=53 Participants	1 Participants n=53 Participants	0 Participants n=125 Participants	11 Participants n=506 Participants
CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C6	0 Participants n=136 Participants	0 Participants n=139 Participants	0 Participants n=53 Participants	0 Participants n=53 Participants	125 Participants n=125 Participants	125 Participants n=506 Participants

PRIMARY outcome

Timeframe: 30 days

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=123 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=119 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.	30.8 score on a scale Standard Deviation 4.22	29.6 score on a scale Standard Deviation 4.73

PRIMARY outcome

Timeframe: 30 days

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=46 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=43 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.	29.3 score on a scale Standard Deviation 4.94	25.0 score on a scale Standard Deviation 6.24

PRIMARY outcome

Timeframe: 30 days

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=125 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=115 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.	31.8 score on a scale Standard Deviation 5.12	32.1 score on a scale Standard Deviation 4.95

PRIMARY outcome

Timeframe: 30 days

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=46 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=43 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.	30.1 score on a scale Standard Deviation 6.39	28.3 score on a scale Standard Deviation 5.58

PRIMARY outcome

Timeframe: Post Index procedure, on the day of the procedure immediately following treatment

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.

Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=137 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=130 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.	92.4 % of vein length Standard Deviation 13.40	91.1 % of vein length Standard Deviation 11.85

PRIMARY outcome

Timeframe: Post Index procedure, on the day of the procedure immediately following treatment

Population: Target Veins based measurement. Number of units analyzed units corresponds to number of target veins with available data.

Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=49 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=44 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.	69.9 % of vein length Standard Deviation 19.93	68.2 % of vein length Standard Deviation 25.82

PRIMARY outcome

Timeframe: 12 months

Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=125 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months.	81.3 percentage probability	—

SECONDARY outcome

Timeframe: 6 months

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=131 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=126 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.	93.9 percentage probability	93.5 percentage probability

SECONDARY outcome

Timeframe: 6 months

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=48 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=43 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.	97.9 percentage probability	92.9 percentage probability

SECONDARY outcome

Timeframe: 6 months

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=125 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.	87.3 percentage probability	—

SECONDARY outcome

Timeframe: 30 days

Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=94 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=85 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.	97.9 percentage probability	97.6 percentage probability

SECONDARY outcome

Timeframe: 30 days

Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=34 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=34 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.	89.0 percentage probability	76.5 percentage probability

SECONDARY outcome

Timeframe: 30 days

Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=42 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.	85.7 percentage probability	—

SECONDARY outcome

Timeframe: 30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=131 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=126 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. 30 days	95.4 percentage probability	95.2 percentage probability
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. 12 months	86.6 percentage probability	89.3 percentage probability

SECONDARY outcome

Timeframe: 30 days, 12 months

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=48 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=43 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months. 30 days	97.9 percentage probability	97.7 percentage probability
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months. 12 months	95.7 percentage probability	92.9 percentage probability

SECONDARY outcome

Timeframe: 30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=125 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. 30 days	91.9 percentage probability	—
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. 12 months	82.3 percentage probability	—

SECONDARY outcome

Timeframe: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with data available at the index procedure.

For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=139 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=132 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. 30 days	95.7 percentage probability	94.6 percentage probability
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. 6 months	93.5 percentage probability	93.1 percentage probability
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. 12 months	86.6 percentage probability	89.0 percentage probability

SECONDARY outcome

Timeframe: 30 days, 6, 12 months

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with data available at the index procedure.

Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=52 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=45 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. 30 days	98.0 percentage probability	97.8 percentage probability
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. 6 months	98.0 percentage probability	93.2 percentage probability
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. 12 months	96.0 percentage probability	93.2 percentage probability

SECONDARY outcome

Timeframe: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with data available at the index procedure.

For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=157 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. 30 days	93.6 percentage probability	—
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. 6 months	89.1 percentage probability	—
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. 12 months	85.2 percentage probability	—

SECONDARY outcome

Timeframe: Post Index procedure, on the day of the procedure immediately following treatment

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.

For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=138 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=130 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.	136 Target Veins	129 Target Veins

SECONDARY outcome

Timeframe: Post Index procedure, on the day of the procedure immediately following treatment

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.

Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=49 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=44 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.	49 Target Veins	44 Target Veins

SECONDARY outcome

Timeframe: Post Index procedure, on the day of the procedure immediately following treatment

Population: Target veins based measurement. Number of analyzed units corresponds to number of target veins with available data.

For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=153 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.	147 Target Veins	—

SECONDARY outcome

Timeframe: 12 months

Population: Rate based measurement; rate corresponds to count of reinterventions over the total vein-years (sum of patient follow-up time until reintervention, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit.	0.06 reintervention per vein-years	0 reintervention per vein-years

SECONDARY outcome

Timeframe: 12 months

Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.

As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=48 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=43 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months.	93.1 percentage probability	100 percentage probability

SECONDARY outcome

Timeframe: 12 months

Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=136 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=139 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. Hypersensitivity to VenaSeal™ adhesive	8 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. Phlebitis	12 Participants	4 Participants
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. Granuloma	1 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. EGIT/EHIT	1 Participants	5 Participants
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. DVT	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. Phlebitis	2 Participants	1 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. Granuloma	0 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. EGIT	0 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. DVT	0 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. Hypersensitivity to VenaSeal™ adhesive	6 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=125 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. Hypersensitivity to VenaSeal™ adhesive	1 Participants	—
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. Phlebitis	13 Participants	—
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. Granuloma	2 Participants	—
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. EGIT	3 Participants	—
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. DVT	2 Participants	—

SECONDARY outcome

Timeframe: 12 months

Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months. Symptomatic pulmonary embolism (PE)	0 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months. Serious adverse events (SAEs)	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Rate based measurement; rate corresponds to the count of adjunctive procedures over the total vein-years (sum of patient follow-up time until adjunct procedure, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=144 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=146 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. Phlebectomy	0.02 adjunctive treatment per vein-years	0.01 adjunctive treatment per vein-years
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. Sclerotherapy	0.1 adjunctive treatment per vein-years	0.08 adjunctive treatment per vein-years

SECONDARY outcome

Timeframe: 12 months

Population: Rate based measurement; rate corresponds to the count of adjunctive procedures over the total vein-years (sum of patient follow-up time until adjunct procedure, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=59 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=57 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. Phlebectomy	0.07 adjunctive treatment per vein-years	0 adjunctive treatment per vein-years
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. Sclerotherapy	0.07 adjunctive treatment per vein-years	0.02 adjunctive treatment per vein-years

SECONDARY outcome

Timeframe: 12 months

Population: Rate based measurement; rate corresponds to the count of adjunctive procedures over the total vein-years (sum of patient follow-up time until adjunct procedure, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=157 Target Veins CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. Sclerotherapy	0.12 adjunctive treatment per vein-years	—
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. Phlebectomy	0 adjunctive treatment per vein-years	—

SECONDARY outcome

Timeframe: 12 months

Population: Rate based measurement; rate corresponds to the count of healthcare utilization over the total person-years (sum of patient follow-up time until Health Care Utilization, 12 months, or exit if before 12 months) among patients in the ITT cohort.

Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. Inpatient Visits	0.0210 services utilized per person-years	0.0228 services utilized per person-years
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. Hospital Outpatient Visits	0.4409 services utilized per person-years	0.1596 services utilized per person-years
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. Clinic Visits	0.0840 services utilized per person-years	0.1824 services utilized per person-years
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. Outpatient ER Visits	0.0210 services utilized per person-years	0.0228 services utilized per person-years

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=53 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Diagnostic Tests Performed: Computed Tomographic Venography	0 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Diagnostic Tests Performed: DUS	4 Participants	2 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Diagnostic Tests Performed: Intravascular Ultrasound	0 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Diagnostic Tests Performed: Magnetic Resonance Venography	0 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Diagnostic Tests Performed: Venogram	0 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Diagnostic Tests Performed: Other	1 Participants	0 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Actions Taken: Medication Change	9 Participants	1 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Actions Taken: Intervention Involving Target Limb/Vein	2 Participants	2 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Hospitalization	1 Participants	1 Participants
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. Other Actions	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days

Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=131 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=126 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.	98.5 percentage probability	96.8 percentage probability

SECONDARY outcome

Timeframe: 30 days

Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=48 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA n=43 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.	95.8 percentage probability	93.0 percentage probability

SECONDARY outcome

Timeframe: 30 days

Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

Outcome measures

Outcome measures
Measure	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System n=125 Participants CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.	80.9 percentage probability	—

SECONDARY outcome

Timeframe: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days