Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

  • STATUS
    Recruiting
  • participants needed
    180
  • sponsor
    Imperial College London
Updated on 18 June 2021
reflux
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Summary

This study will be comparing the treatment of varicose veins using either mechanochemical ablation (MOCA) or cyanoacrylate adhesive (CAE). Patients will be randomised to receiving either MOCA or CAE.

The pain scores, clinical scores, quality of life scores, occlusion and re-intervention rate at 2 weeks, 3, 6 and 12 months as well as the cost effectiveness of each intervention will be assessed.

Description

This will be a randomised clinical trial comparing MOCA to CAE. Patients will be randomised into group A (MOCA) or group B (CAE). Only the endovenous ablation part of the procedure will be randomised while the decision as to whether patients should receive treatment of their varicose tributaries will be at the discretion of the clinical team.

The device used for MOCA (group A) will be the ClariVein mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).

The device used for CAE (group B) will be the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).

Re-intervention of the treated saphenous veins will not be decided until at least 3 months after their initial procedure.

Details
Condition Varices, Vascular Diseases, Varicose Veins, varix
Treatment Mechanochemical ablation, Cyanoacrylate adhesive
Clinical Study IdentifierNCT03392753
SponsorImperial College London
Last Modified on18 June 2021

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