VARICO 2 TRIAL: Prospective randomised trial analyzing results after Radiofrequency Obliteration VNUS ClosureFAST and Endovenous Laser Ablation ELVeS Radial Fiber 1470nm using local timescent anaesthesia for great saphenous vein incompetence.
Completed
- Conditions
- Recovery, complications, Quality of Life, pain, occlusion- and recurrence rate, tumescent anaesthesia.Herstel, complicaties, kwaliteit van leven, pijn, herontstaan spataderen na behandeling, tumescentie.
- Registration Number
- NL-OMON21594
- Lead Sponsor
- Ab Aquapendente Research
- Brief Summary
James A. Lawson, MD, PhD,a Stefanie A. Gauw, CRC,a Clarissa J. van Vlijmen, MD, PhD,a Pascal Pronk, MD,a Menno T. W. Gaastra, MD,a Marco J. Tangelder, MD, PhD,b and Michael C. Mooij, MD. Prospective comparative cohort study evaluating incompetent great saphenous vein closure using radiofrequency-powered segmental ablation or 1470-nm endovenous laser ablation with radial-tip fibers (Varico 2 study). Journal of Vascular Surgery: Venous and Lymphatic Disorders. January 2018. Volume 6, Number 1: 31-40.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. Incompetence of great saphenous vein, (reflux >0,5 seconds);
2. Lenght of treated vein >15 cm;
Exclusion Criteria
1. Primary treatment of great saphenous vein incompetence;
2. Pregnancy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occlusion- and recurrence rate.
- Secondary Outcome Measures
Name Time Method 1. Quality of Life;<br /><br>2. Complications;<br /><br>3. Pain.