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Experimental vein valve repair device tested in 14 patients, trial halted early

NCT ID NCT03216005

Disease control Sponsor: Intervene, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tested a device called the BlueLeaf System to fix faulty valves in leg veins of people with chronic venous insufficiency (CVI). The goal was to see if it could safely reduce backward blood flow and improve symptoms. Only 14 people took part before the trial was stopped. The main measures were changes in vein reflux time and risk of blood clots.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Nov 2017

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6; * Failed compression therapy of at least 6 months' duration; * Deep system venous reflux characterized by \>1 second reflux time; * Presence of at least one target site within the target vessel. Exclusion Criteria: * Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms; * Deep venous intervention in the target limb or outflow vessels within 6 months of consent; * Significant peripheral arterial disease with an ankle-brachial index of \<0.50 or with incompressible vessels; * Acute deep venous thrombosis (DVT) within 3 months of consent; * History of stroke within the last 6 months; * Flow-limiting venous outflow obstruction central to the intended target sites; * Insufficient inflow through the treatment vein upon manual augmentation; * Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites; * Chronic renal insufficiency with creatinine level of ≥2mg/dL; * Hemoglobin level \<9.0 mg/dL; * Platelet count \<50,000 or \>1,000,000 per mm3; * Total white blood cell count \<3,000/mm3; * Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested; * Non-ambulatory patients;

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency

As listed by the trial registrant

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

Chronic venous insufficiency

Contacts and locations

Locations

  • Auckland City Hospital

    Auckland, New Zealand

  • Clinical Trials New Zealand Ltd

    Hamilton, New Zealand

  • Prince of Wales

    Randwick, New South Wales, 2031, Australia

  • Royal Prince Alfred

    Camperdown, New South Wales, 2050, Australia

  • Vancouver Coastal Health Research Institute

    Vancouver, British Columbia, V5Z 1M9, Canada

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