CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
Ablation of the Incompetent Greater Saphenous Vein +2 moreprocedure
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/NCT02236338
NCT02236338Phase 4Completed

Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein: A Prospective Randomized Trial

Virginia Commonwealth University·interventional·Posted Sep 10, 2014·Updated May 14, 2018

In Brief

A Phase 4 clinical trial evaluating Ablation of the Incompetent Greater Saphenous Vein, ClosureFAST radiofrequency catheter, and 1 other intervention for Chronic Venous Insufficiency. Completed, enrolled 200 participants across 1 site.

Detailed Summary

The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency, in an effort to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2014
Enrollment StartSep 1, 2008
Primary CompletionAug 11, 2016
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 11.8 years ago

Interventions

Ablation of the Incompetent Greater Saphenous Veinprocedure

For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.

ClosureFAST radiofrequency catheterdevice

EVLT 980nm diode laser systemdevice