Trial Outcomes & Findings for A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency (NCT NCT03311269)

Last Updated: 2022-03-02

Results Overview

The VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study Quality of Life) comprises 25 items that quantify disease effect on quality-of-life, \& a symptom questionnaire (VEINES-Sym) with 10 items that measure physical symptoms. A subset of the reported symptoms to Question 1 of the VEINES QOL/Sym is referred to as the 7-Day Symptom Questionnaire was used in this study. Subject response to each symptom was rated on a common 4-point response scale with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Weekly average score was calculated if at least 4 daily scores were present in the previous week. Daily total symptom score derived as sum of the responses across all symptoms (range = 5 to 20) Improvement in patient reported symptoms using the 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing \& Itching) at post-treatment Week 12 compared to Baseline is the primary endpoint of this study.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	ClariVein RES 1% Injection Sodium Tetradecyl Sulfate 1% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection	ClariVein RES 3% Injection Sodium Tetradecyl Sulfate 3% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection
Overall Study STARTED	10	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ClariVein RES 1% Injection n=10 Participants Sodium Tetradecyl Sulfate 1% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection	ClariVein RES 3% Injection n=9 Participants Sodium Tetradecyl Sulfate 3% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Body Mass Index (BMI)	25.6 kg/m2 STANDARD_DEVIATION 4.54 • n=5 Participants	27.1 kg/m2 STANDARD_DEVIATION 5.35 • n=7 Participants	26.3 kg/m2 STANDARD_DEVIATION 4.86 • n=5 Participants
Ultrasound Parameters at Screening: Leg Assessed Right	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ultrasound Parameters at Screening: Leg Assessed Left	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Retrograde Flow	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Patient-Reported Symptoms 7-Day Symptom Questionnaire (Average Daily Total Symptom Score	10.6 units on a scale STANDARD_DEVIATION 3.39 • n=5 Participants	11.3 units on a scale STANDARD_DEVIATION 4.18 • n=7 Participants	10.9 units on a scale STANDARD_DEVIATION 3.76 • n=5 Participants
Saphenous Vein Reflux	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Length of Vein Section to be Treated	37.8 centimeters (cm) STANDARD_DEVIATION 6.49 • n=5 Participants	34.6 centimeters (cm) STANDARD_DEVIATION 15.27 • n=7 Participants	36.3 centimeters (cm) STANDARD_DEVIATION 11.29 • n=5 Participants
Diameter of Vein Section to be Treated	5.41 centimeters (cm) STANDARD_DEVIATION 0.845 • n=5 Participants	9.08 centimeters (cm) STANDARD_DEVIATION 7.490 • n=7 Participants	7.15 centimeters (cm) STANDARD_DEVIATION 5.369 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	ClariVein RES 1% Injection n=10 Participants Sodium Tetradecyl Sulfate 1% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection	ClariVein RES 3% Injection n=9 Participants Sodium Tetradecyl Sulfate 3% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection
Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.	7.2 units on a scale Standard Deviation 3.00	6.2 units on a scale Standard Deviation 1.87

SECONDARY outcome

Timeframe: 12 weeks

Evaluated by way of duplex ultrasound and read by Core Lab. Elimination of saphenous vein reflux can be achieved when ultrasound images demonstrate vein closure (no discrete open segment of vein \> 5cm in length within the treatment section of the selected saphenous vein), or vein competency (defined as absence of retrograde flow \> 0.5 seconds within any open portions of the treatment section of the selected saphenous vein) as assessed by duplex ultrasound. Responder = subjects who satisfies criteria for elimination of saphenous vein reflux

Outcome measures

Outcome measures
Measure	ClariVein RES 1% Injection n=10 Participants Sodium Tetradecyl Sulfate 1% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection	ClariVein RES 3% Injection n=9 Participants Sodium Tetradecyl Sulfate 3% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection
Elimination of Saphenous Vein Reflux Vein Closure : Yes	5 Participants	9 Participants
Elimination of Saphenous Vein Reflux Vein Closure : No	5 Participants	0 Participants
Elimination of Saphenous Vein Reflux Vein Closure : Missing	0 Participants	0 Participants
Elimination of Saphenous Vein Reflux Vein Competency : Yes	2 Participants	0 Participants
Elimination of Saphenous Vein Reflux Vein Competency : No	3 Participants	0 Participants
Elimination of Saphenous Vein Reflux Vein Competency : Missing	0 Participants	0 Participants
Elimination of Saphenous Vein Reflux Vein Competency: No open segments > 5cm	5 Participants	9 Participants
Elimination of Saphenous Vein Reflux Saphenous Vein Reflux: Non-Responder	3 Participants	0 Participants
Elimination of Saphenous Vein Reflux Saphenous Vein Reflux: Responder	7 Participants	9 Participants

Adverse Events

ClariVein RES 1% Injection

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

ClariVein RES 3% Injection

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ClariVein RES 1% Injection n=10 participants at risk Sodium Tetradecyl Sulfate 1% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection	ClariVein RES 3% Injection n=9 participants at risk Sodium Tetradecyl Sulfate 3% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection
Skin and subcutaneous tissue disorders Blister	10.0% 1/10 • Number of events 1 • AE data collection began after ICF is signed and continued until completion of subject's Week 12 post-treatment follow-up visit (Visit 6). Any AE or SAE having an onset after the completion of Visit 6 (end of the study visit) was not collected or reported unless the Investigator determined event to be related to the study drug.	0.00% 0/9 • AE data collection began after ICF is signed and continued until completion of subject's Week 12 post-treatment follow-up visit (Visit 6). Any AE or SAE having an onset after the completion of Visit 6 (end of the study visit) was not collected or reported unless the Investigator determined event to be related to the study drug.
Vascular disorders Thrombophlebitis Superficial	0.00% 0/10 • AE data collection began after ICF is signed and continued until completion of subject's Week 12 post-treatment follow-up visit (Visit 6). Any AE or SAE having an onset after the completion of Visit 6 (end of the study visit) was not collected or reported unless the Investigator determined event to be related to the study drug.	22.2% 2/9 • Number of events 2 • AE data collection began after ICF is signed and continued until completion of subject's Week 12 post-treatment follow-up visit (Visit 6). Any AE or SAE having an onset after the completion of Visit 6 (end of the study visit) was not collected or reported unless the Investigator determined event to be related to the study drug.
General disorders Infusion Site Bruising	10.0% 1/10 • Number of events 1 • AE data collection began after ICF is signed and continued until completion of subject's Week 12 post-treatment follow-up visit (Visit 6). Any AE or SAE having an onset after the completion of Visit 6 (end of the study visit) was not collected or reported unless the Investigator determined event to be related to the study drug.	11.1% 1/9 • Number of events 1 • AE data collection began after ICF is signed and continued until completion of subject's Week 12 post-treatment follow-up visit (Visit 6). Any AE or SAE having an onset after the completion of Visit 6 (end of the study visit) was not collected or reported unless the Investigator determined event to be related to the study drug.

Additional Information

Ms. Lorraine Hanley, MBA

Vascular Inisights, LLC

Phone: 617-519-1109

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place