NCT01722019: VNUS vs TULIP

Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diode Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.

Completed NA Last updated 29 December 2022

What this trial tests

NA trial testing Tulip fiber in Chronic Venous Insufficiency C2 or Higher in 280 participants. Completed in 31 August 2022.

Timeline

1 January 2014

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	280
Start date	1 January 2014
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	3 locations across Belgium

Drugs / interventions tested

• Tulip fiber
• VNUS closure fast

Conditions studied

• Chronic Venous Insufficiency C2 or Higher — all drugs for Chronic Venous Insufficiency C2 or Higher →

Sponsor

University Hospital, Ghent

Who can join

Adults 18 to 75, any sex, with Chronic Venous Insufficiency C2 or Higher. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. According to the trial of Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in observational studies. The aim of this study is to compare radiofrequency ablation with the VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point necroses of the vessel wall and on consequence results in lesser side effects from wall perforations such as pain, haematoma,…

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.