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.

Not Applicable

Completed

• Conditions: Chronic Venous Insufficiency C2 or Higher

• Registration Number: NCT01722019
• Lead Sponsor: University Hospital, Ghent

Brief 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,...

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Study Start: 2014-01-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Endovenous ablation of the great saphenous vein (GSV) planned
• Patient signed informed consent
• Patient must complete the 1 year follow-up
• CEAP between 2 and 6
• BMI=<35
• Diameter of the GSV in upward position less than 20 mm diameter
• No problems in deep venous system

Exclusion Criteria

• No informed consent is signed
• Latex allergy
• Arterial insufficiency
• Deep vein thrombosis or deep vein insufficiency
• Klippel Trenaunay
• Diameter fo GSV > 20 mm
• Cross dilation with 2 or more insufficient side branches
• Previous GSV operation
• Redo-operation
• Carcinoma less than 1 year ago
• BMI > 35
• Liver-insufficiency with contraindication for local tumescence
• Intake of warfarins
• Pregnancy, breastfeeding, < 3 months after pregnancy
• Bilateral GSV insufficiency that has to be treated
• Cross insufficiency of the accessory saphenous vein or insufficiency of the subterminal valve of the GSV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Closure of the greater saphenous vein at 12 months.	12 months after procedure	Closure of the greater saphenous vein will be measured by venous duplex, Kabnick score and modified Gelev score. This will be performed after 5 days, 1 month, 6 months and 12 months.

Secondary Outcome Measures

Name	Time	Method
Pain.	after 1 year.	This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Incapacity to work.	After 1 year	This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Patient satisfaction rate.	After 1 year.	This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Pain satisfaction rate.	After 6 months	This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

Trial Locations

Locations (3)

Ghent University Hospital; 🇧🇪 Ghent, Belgium

University Hospital Leuven; 🇧🇪 Leuven, Belgium

Sint-Andriesziekenhuis Tielt; 🇧🇪 Tielt, Belgium