MedTrace Logo

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

NCT01936168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2021-02-12

No results posted yet for this study

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

  • Greater Saphenous Vein Injury

Interventions

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

Sponsors & Collaborators

  • St. Antonius Hospital

    collaborator OTHER

  • OLVG

    collaborator NETWORK

  • BovenIJ Hospital

    collaborator OTHER

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • MMPJ Reijnen, MD · Rijnstate Hospital Arnhem

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936168 on ClinicalTrials.gov