Clinical Investigation of Safety and Effectiveness for the enVVe® System
NCT07609927 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2026-05-27
Summary
A staged prospective, randomized, non-blinded, multicenter study.
Conditions
- Chronic Venous Insufficiency, CVI
Interventions
- DEVICE
-
envve system
Catheter based valve system
Sponsors & Collaborators
-
NAMSA
collaborator OTHER -
Hancock Jaffe Laboratiores, Inc
lead NETWORK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2029-07-01
- Completion
- 2033-07-01
- FDA Device
- Yes
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