Clinical Trials Directory

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

TypeNameDescription
DEVICEMechanochemical Endovenous Ablation (MOCA)Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence
PROCEDURERadiofrequency 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.