Study

Recruiting Not a phased study

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Not a phased study
Sponsor InnoVein
Registry number NCT04253301
Started 15 January 2020 Today 16 October 2026 Estimated completion 15 February 2022

Past estimated completion. The registry still lists this trial as open, and the date it gave for finishing has been and gone. Confirm with the official record before you act on it.

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Hollywood Private Hospital Nedlands WA Recruiting
Sir Charles Gairdner Hospital Nedlands WA Recruiting
Flinders Adelaide Australia Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 5

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Key Inclusion Criteria:

* Willing and able to provide written Informed Consent

* Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein

* Willing and medically able to receive intraprocedural and post-procedural anticoagulation medication

* Life expectancy \>1yr

* Reflux time \>1s in the superficial femoral and/or popliteal vein

Key Exclusion Criteria:

* Any prior deep vein intervention within 6 months prior to the Index Procedure

* History of 2+ DVTs

* Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or IVC

* Current IVC Placement

* History of pulmonary embolism within 6 months

* Conditions that increase the risk of device thrombosis or patient bleeding

* Any planned surgical or interventional procedure within 30 days prior to or after the Index Procedure

* Investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol

Dates on the record

Started 15 January 2020
Estimated completion 15 February 2022
Registry last updated 17 September 2021
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 17 September 2021.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.