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Cook Venous Valve System for Treatment of Chronic Venous Insufficiency

StatusActive, Not Recruiting
PhaseNot applicable
Started2023-04-24
View on ClinicalTrials.gov ↗
The purpose of this study is to learn about the safety, efficacy and utility of a medical device called the Cook® Venous Valve System. This device, percutaneously placed in the leg, is meant to help the blood flow correctly through the veins in the leg.

Amendment record

Amended 4 times since 2023-05-29; most recent filed 2026-05-15. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-05-15
Amendment Study Status, Oversight, IPDSharing v4
2025-05-15
Amendment Study Status, Oversight, IPDSharing v3
2024-05-21
Amendment Study Status v2
2023-11-27
Amendment Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v1
2023-05-29
Original filing
Trial Details
NCT Number NCT05883943
Lead Sponsor MED Institute Inc.
Conditions Venous Insufficiency of Leg
Enrollment 4 participants
Start Date 2023-04-24
Primary Completion 2023-09-23 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-19