Trial Outcomes & Findings for SeCure Endovenous Laser Treatment Study (NCT NCT02215369)
NCT ID: NCT02215369
Last Updated: 2020-05-19
Results Overview
The primary effectiveness endpoint is "Acute Primary Ablation Success" defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
10 day
Results posted on
2020-05-19
Participant Flow
Unit of analysis: Veins
Participant milestones
| Measure |
VenaCure EVLT 400 µm Fiber Procedure Kit
Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.
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|---|---|
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Overall Study
STARTED
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112 146
|
|
Overall Study
COMPLETED
|
70 113
|
|
Overall Study
NOT COMPLETED
|
42 33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SeCure Endovenous Laser Treatment Study
Baseline characteristics by cohort
| Measure |
VenaCure EVLT 400 µm Fiber Procedure Kit
n=83 Participants
Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.
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|---|---|
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Age, Continuous
|
63.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
BMI
|
30.2 kg/m^2
STANDARD_DEVIATION 5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 dayPopulation: Intent to Treat (ITT) Population
The primary effectiveness endpoint is "Acute Primary Ablation Success" defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure.
Outcome measures
| Measure |
VenaCure EVLT 400 µm Fiber Procedure Kit
n=125 Veins
Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.
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|---|---|
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Acute Primary Ablation Success
|
96 Veins
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SECONDARY outcome
Timeframe: TreatmentPopulation: Intent to Treat (ITT) Population
Technical Success, defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended laser energy, will be evaluated as a secondary endpoint for inclusion in device labeling.
Outcome measures
| Measure |
VenaCure EVLT 400 µm Fiber Procedure Kit
n=125 Veins
Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.
|
|---|---|
|
Technical Success
|
119 Veins
|
Adverse Events
VenaCure EVLT 400 µm Fiber Procedure Kit (Safety Population)
Serious events: 9 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
VenaCure EVLT 400 µm Fiber Procedure Kit (Safety Population)
n=93 participants at risk
Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.
|
|---|---|
|
Infections and infestations
Abscess limb
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Immune system disorders
Immune thrombocytopenic purpura
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Peripheral venous disease
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Infections and infestations
Pneumonia legionella
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Metabolism and nutrition disorders
Metabolic encephalopathy
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Skin ulcer
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Nervous system disorders
Craniocerebral injury
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Septic shock
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
Other adverse events
| Measure |
VenaCure EVLT 400 µm Fiber Procedure Kit (Safety Population)
n=93 participants at risk
Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.
|
|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
General disorders
Peripheral swelling
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
General disorders
Procedural pain
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Injury, poisoning and procedural complications
Seroma
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Injury, poisoning and procedural complications
Wound
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Musculoskeletal and connective tissue disorders
Spinal fracture
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Renal and urinary disorders
Urinary tract infection
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/93 • Number of events 2 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Skin and subcutaneous tissue disorders
Angiodermatitis
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Skin and subcutaneous tissue disorders
Laceration
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Skin and subcutaneous tissue disorders
Skin injury
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Arterial restenosis
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Bleeding varicose vein
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Deep vein thrombosis
|
3.2%
3/93 • Number of events 3 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Skin ulcer
|
3.2%
3/93 • Number of events 3 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Thrombophlebitis superficial
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Varicose vein
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Venous occlusion
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
|
Vascular disorders
Venous thrombosis limb
|
1.1%
1/93 • Number of events 1 • 12 months
The safety population was used for all adverse event reporting and analyses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place