Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endov… (NCT01722019) | Clinical Trial Compass
CompletedNot Applicable
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.
Belgium280 participantsStarted 2014-01-01
Plain-language 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,…
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Closure of the greater saphenous vein at 12 months.