Tiny trial tests artificial vein valve for leg swelling

NCT ID NCT05883943

Ongoing Disease control Sponsor: MED Institute Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a new device called the Cook® Venous Valve System in just 4 people with chronic venous insufficiency (leg veins that don't pump blood back to the heart properly). The valve is implanted through a small tube into a deep leg vein to help blood flow one way. The main goal is to check safety in the first 30 days, with follow-ups up to a year.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Cook® Venous Valve System (a permanent prosthetic valve implanted in the leg vein)
What this could lead to: If it works, this could offer a new treatment option for chronic venous insufficiency, potentially reducing leg swelling and pain.
What could go wrong: This is a very early, tiny study with only 4 people. The device may not work as hoped, and risks include blood clots, bleeding, or device movement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency venous insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

VENOUS INSUFFICIENCY OF LEG

Contacts and locations

Locations

Angiosur S.A.S.

Antioquia, Colombia
Clínica de La Costa S.A.S.

Barranquilla, Colombia
Fundacion Oftalmologica De Santander

Santander, Colombia

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