Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03311269
Eligibility Criteria:
Inclusion Criteria:
1. Adult patient with incompetent saphenous vein
2. Saphenous vein reflux \> 500ms (0.5s), as measured by duplex ultrasound
3. One or more of patient reported symptoms related to the target vein: i.e., heaviness, achiness, swelling, throbbing or itching.
4. Candidate for endovenous procedure
Exclusion Criteria:
1. Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD) that would preclude the wearing of compression stockings
2. Absence of a palpable pulse at posterior tibial or dorsalis pedis and an Ankle-Brachial Index (ABI) \<0.6
3. Multi-segmental axial deep venous reflux in at least two contiguous venous segments (e.g., femoral and popliteal) in the ipsilateral extremity
4. Previous surgical or endovenous procedure in the treatment section of the target vein
5. Previous superficial thrombophlebitis of the target saphenous vein with scarring in the treatment section
6. Pregnant or breastfeeding
7. Known sensitivity or allergic response to Sodium Tetradecyl Sulfate (STS)
8. Known high risk of thrombosis
9. Known history of deep vein thrombus (DVT) or pulmonary embolism (PE), known history of acute superficial vein thrombus, known hypercoagulable condition, post thrombotic syndrome
10. Known history of anaphylaxis or presence of multiple severe allergies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03311269
Study Brief:
Protocol Section:
NCT03311269