MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins (NCT01936168) | Clinical Trial Compass
CompletedNot Applicable
MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins
Netherlands213 participantsStarted 2016-12-01
Plain-language summary
The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.
Who can participate
Age range
18 Years – 80 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:
* Insufficiency of the GSV
* Signed informed consent
* Patient willing to participate in follow-up scheme
* Age \> 18 years
* Ultrasound criteria for endovenous treatment have been met:
* Diameter GSV between 3-12 mm
* No thrombus in the to be treated segment of the GSV
Exclusion Criteria:
* Patient not able to give informed consent
* Patient unable to present at follow-up visits
* Other treatment is more suitable
* Pregnancy and breast feeding
* Known allergy/ contra-indication for sclerotherapy
* Previous ipsilateral surgical treatment of varicose veins
* Deep venous thrombosis or lung emboli in medical history
* Anticoagulant therapy
* C5-C6 varices
* Immobilization
* Fontaine II or IV peripheral arterial disease
* Severe kidney function decline (GFS \< 30 mL/min)
* Coagulation disorder or increased risk for thrombo-embolic complications(hemofilie A or B, v. Willebrand disease, Glanzmann disease, Factor VII-deficiency, idiopatic thrombocytopenic purpura, Factor V Leiden)
* Liver diseases accompanied by changes in blood coagulation, livver cirrhosis
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.