An interventional study of Mechanochemical Endovenous Ablation (MOCA) and Radiofrequency ablation (RFA) in Greater Saphenous Vein Injury, sponsored by Rijnstate Hospital. Completed at 5 sites in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Treatment
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.
253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.
This study's enrollment of 213 is above the median of 104 across 162 interventional studies indexed under Varicose Veins.
Browse Varicose Veins studies →Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Radiofrequency Ablation (RFA)
Procedure: Radiofrequency ablation (RFA)
Mechanochemical Endovenous Ablation (MOCA)
Device: Mechanochemical Endovenous Ablation (MOCA)
Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence
Also known as: (MOCA)
Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence
Also known as: (RFA)
Occlusion rate
Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success)
Time frame: up to 5 years
Per-procedural pain score
Pain during the procedure will be compared between treatments using the VAS score
Time frame: two weeks
Complications
Complication at day 30 will be compared between treatments.
Time frame: 30 days
Procedure duration
The duration of the procedures will be compared
Time frame: 30 days
Costs of both treatments
The total costs of both treatments will be compared
Time frame: 1 year
Health status
Using the RAND 36-Item short From Health Survey (SF36) the general health status will be compared between treatments at various time points as specified by the protocol.
Time frame: 1 year, 5 years
Post procedural pain score
Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score
Time frame: two weeks
Disease related quality of life
Using the Aberdeen Varicose Vein Questionnaire (AVVQ)the disease related quality of life will be compared between treatments at various time points as specified by the protocol.
Time frame: 1 year, 5 years
Recovery time
Time until daily activities and or work can be resumed (measured in days)
Time frame: 30 days
Plan to share: Yes
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Rijnstate Hospital