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NCT01936168: MARADONA
MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins
NA trial testing Mechanochemical Endovenous Ablation (MOCA) in Greater Saphenous Vein Injury in 213 participants. Completed in 31 December 2020.
31 December 2020
Quick facts
| Lead sponsor | Rijnstate Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 213 |
| Start date | 1 December 2016 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 5 locations across Netherlands |
Drugs / interventions tested
- Mechanochemical Endovenous Ablation (MOCA)
- Radiofrequency ablation (RFA)
Conditions studied
- Greater Saphenous Vein Injury — all drugs for Greater Saphenous Vein Injury →
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):
-
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
Verify or expand the search:
- PubMed search for NCT01936168
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01936168 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rijnstate Hospital
- Last refreshed: 12 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01936168.
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