Mechanochemical Ablation Compared to Cyanoacrylate Adhesive
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|ClinicalTrials.gov Identifier: NCT03392753|
Recruitment Status : Completed
First Posted : January 8, 2018
Results First Posted : December 7, 2021
Last Update Posted : August 4, 2022
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||Not Applicable|
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)|
|Actual Enrollment :||167 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|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||December 31, 2021|
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 immediately following vein ablation ]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 following vein ablation and any tributary treatment ]Pain score at the end of the procedure using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
- Generic Quality of Life as Per EQ-5D Questionnaire [ Time Frame: Recorded at 12 months ]Using the EuroQoL's EQ-5D questionnaire (-0.085=worse quality of life; 1.000=best quality of life)
- Disease Specific Quality of Life as Per the AVVQ [ Time Frame: Recorded at 12 months ]Using the Aberdeen Varicose Vein Questionnaire (AVVQ) questionnaire (0=best quality of life; 100=worse quality of life)
- Disease Specific Quality of Life as Per the CIVIQ-20 [ Time Frame: 12 months ]Using the CIVIQ-20 questionnaire (0=best quality of life; 100=worse quality of life)
- Clinical Change as Per VCSS [ Time Frame: 12 months ]Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)
- Pain Score Over the First 10 Days [ Time Frame: For the first 10 days since procedure ]Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain). The mean pain score was recorded daily and a mean value was calculated.
- 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). The outcome measured is the number of participants with a degree of bruising between category 0-1.
- Time to Return to Normal Activities [ Time Frame: 2 weeks ]Length of time in days until normal activities are resumed
- Occlusion Rates [ Time Frame: 12 months ]Rate of occlusion as assessed by duplex ultrasound
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392753
|Charing Cross Hospital, Imperial College London|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Alun H Davies||Imperial College London|