NCT01722019

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.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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,…

Conditions

• Chronic Venous Insufficiency C2 or Higher

Interventions

Type	Name	Description
DEVICE	Tulip fiber	Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.
DEVICE	VNUS closure fast	Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.

Timeline

• Start date: 2014-01-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2012-11-06
• Last updated: 2022-12-29

Locations

3 sites across 1 country: Belgium