CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veinsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04386785
NCT04386785N/ACompleted
CompareCT.gov

Investigator Initiated Safety Study Using the Venclose Vestico (Commercial Name TBD) Radiofrequency (RF) Ablation System for the Treatment of Incompetent Perforator Veins (IPVs)

Venclose, Inc.·interventional·Posted May 13, 2020·Updated May 27, 2022

In Brief

A clinical study evaluating Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins for Chronic Venous Insufficiency. Completed, enrolled 27 participants across 1 site.

Detailed Summary

A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Venous Insufficiency
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 13, 2020
Enrollment StartMay 23, 2020
Primary CompletionApr 13, 2021
Study CompletionMay 13, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.1 years ago

Interventions

Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veinsdevice

The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.