CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 242 enrolled
Drug / intervention
VenaSeal SCS +2 moredevice
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/NCT01807585
NCT01807585N/ACompleted
CompareCT.gov

VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins

Medtronic Endovascular·interventional·Posted Mar 8, 2013·Updated Jun 26, 2018

In Brief

A clinical study evaluating VenaSeal SCS, ClosureFast Radiofrequency Ablation (RFA), and 1 other intervention for Great Saphenous Vein (GSV) With Venous Reflux Disease. Completed, enrolled 242 participants across 10 sites.

Detailed Summary

The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGreat Saphenous Vein (GSV) With Venous Reflux Disease
CountriesUnited States
CollaboratorsSapheon, Inc.

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2013
Enrollment StartMar 1, 2013
Primary CompletionDec 1, 2013
Study CompletionApr 10, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.3 years ago

Interventions

VenaSeal SCSdevice

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

ClosureFast Radiofrequency Ablation (RFA)device

Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.

Roll-in (VenaSeal SCS)device

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.