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NCT01936168: MARADONA

MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins

Completed NA Last updated 12 February 2021
What this trial tests

NA trial testing Mechanochemical Endovenous Ablation (MOCA) in Greater Saphenous Vein Injury in 213 participants. Completed in 31 December 2020.

Timeline
1 December 2016
Primary endpoint
31 December 2020
31 December 2020

Quick facts

Lead sponsorRijnstate Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment213
Start date1 December 2016
Primary completion31 December 2020
Estimated completion31 December 2020
Sites5 locations across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Rijnstate Hospital

Who can join

Adults 18 to 80, any sex, with Greater Saphenous Vein Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial.
    van Eekeren RR, Boersma D, Holewijn S, Vahl A, et al · · 2014 · cited 23× · PMID 24726004 · DOI 10.1186/1745-6215-15-121

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