Clinical Investigation of Safety and Effectiveness for the enVVe® System (NCT07609927) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Clinical Investigation of Safety and Effectiveness for the enVVe® System
220 participantsStarted 2026-07-01
Plain-language summary
A staged prospective, randomized, non-blinded, multicenter study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Persistent symptoms with at least 3 months of routine care including compression therapy, pneumatic compression, and in C6 patients, wound care with FDA approved medications or dressing solutions
. Axial deep reflux \>1 sec. in the femoral vein (above the P1 segment) and popliteal vein
. Primary or Secondary deep venous valvular incompetence
. CEAP score: C4b, C4c, C5, or C6
. Age ≥18 years
. Ability to stand for duplex ultrasound
. Ability to ambulate without assistance with appropriate heel to toe ambulation
. Able to attend scheduled post-treatment follow-up visits
Exclusion criteria
. Known hypercoagulable condition including Factor V Leiden deficiency (homozygote), Prothrombin gene Mutation (homozygote), Antithrombin 3 deficiency, Protein C deficiency, Protein S deficiency and Antiphospholipid antibody
. Any active cancer or cancer within 6 months of remission (excluding non-melanoma skin cancer)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.