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 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT03835559
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 80 years of age at the time of enrollment
* Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva's maneuver in the standing or reverse Trendelenburg position
* Diameter of saphenous vein between 2mm to 20mm (with standing position)
* One or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling
* Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5
Exclusion Criteria:
* Previous treatment in targeted vein segment
* Tortuous vein in which the delivery catheter cannot be inserted
* Aneurysm of target vein segment \>20 mm
* Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux
* Known hypercoagulable disorder
* Active malignancy
* Regular use of systemic anticoagulation
* Current use of systemic anticoagulant
* Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis
* Unable to comply with the schedule and protocol evaluations
* Unable to ambulate
* Currently pregnant or breast feeding
* Known sensitivity to cyanoacrylate adhesives
* Symptomatic peripheral arterial disease with ankle-brachial index \<0.9
* Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment
* Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03835559
Study Brief:
Protocol Section:
NCT03835559