Mechanochemical Ablation Compared to Cyanoacrylate Adhesive
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|ClinicalTrials.gov Identifier: NCT03392753|
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Varicose Veins||Procedure: Mechanochemical ablation Procedure: Cyanoacrylate adhesive||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||An internet-based randomisation service will be used Outcome assessors will be blinded as to treatment offered|
|Official Title:||Randomised Controlled Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||November 5, 2018|
|Estimated Study Completion Date :||November 5, 2019|
Active Comparator: Mechanochemical ablation (MOCA)
Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).
Procedure: Mechanochemical ablation
Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)
Active Comparator: Cyanoacrylate adhesive (CAE)
Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).
Procedure: Cyanoacrylate adhesive
Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
- Pain score during ablation [ Time Frame: On day 0 ]Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
- Pain score at the end of the procedure [ Time Frame: On day 0 ]Pain score at the end of the procedure using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
- Quality of life [ Time Frame: 12 months ]Using the EuroQoL's EQ-5D questionnaire
- Quality of life [ Time Frame: 12 months ]Using the Aberdeen Varicose Vein Questionnaire (AVVQ) questionnaire
- Quality of life [ Time Frame: 12 months ]Using the CIVIQ questionnaire
- Clinical change [ Time Frame: 12 months ]Using the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification
- Clinical change [ Time Frame: 12 months ]Using the Venous Clinical Severity Score (VCSS)
- Pain score over the first 10 days [ Time Frame: 2 weeks ]Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
- Degree of bruising at 2 weeks [ Time Frame: 2 weeks ]Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment)
- Time to return to normal activities [ Time Frame: 2 weeks ]
- Occlusion rates [ Time Frame: 12 months ]
- Re-intervention rates [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392753
|Contact: Amjad Belrammanemail@example.com|
|Contact: Roshan Bootunfirstname.lastname@example.org|
|Charing Cross Hospital, Imperial College London||Recruiting|
|London, United Kingdom, W6 8RF|
|Contact: Amjad Belramman +442033117335 email@example.com|
|Contact: Roshan Bootun +442033117335 firstname.lastname@example.org|
|Principal Investigator: Alun H Davies|
|Sub-Investigator: Tristan RA Lane|
|Sub-Investigator: Roshan Bootun|
|Sub-Investigator: Amjad Belramman|
|Principal Investigator: Tjun Y Tang|
|Principal Investigator:||Alun H Davies||Imperial College London|