Trials / Completed
CompletedNCT01936168
MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins
Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 213 (actual)
- Sponsor
- Rijnstate Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mechanochemical Endovenous Ablation (MOCA) | Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence |
| PROCEDURE | Radiofrequency ablation (RFA) | Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2013-09-05
- Last updated
- 2021-02-12
Locations
5 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01936168. Inclusion in this directory is not an endorsement.