Clinical trial NCT03392753: Mechanochemical Ablation Compared to Cyanoacrylate Adhesive
Official title: Randomised Controlled Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2018-01-08
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Adults over 18 years of age
* Symptomatic GSV or SSV vein reflux \> 0.5 seconds on colour Duplex

Exclusion Criteria:

* Current DVT
* Recurrent varicose veins
* Arterial disease (ABPI\<0.8)
* Vein diameter \< 3mm
* Patient who are unwilling to participate
* Inability or unwillingness to complete questionnaires
* Adverse reaction to sclerosant or cyanoacrylate
* Not been involved in another venous trial for at least 6 months

Primary outcomes:
measure: Pain Score During Ablation
timeFrame: On day 0 immediately following vein ablation
Secondary outcomes:
measure: Pain Score at the End of the Procedure
timeFrame: On day 0 following vein ablation and any tributary treatment
measure: Generic Quality of Life as Per EQ-5D Questionnaire
timeFrame: Recorded at 12 months
measure: Disease Specific Quality of Life as Per the AVVQ
timeFrame: Recorded at 12 months
measure: Disease Specific Quality of Life as Per the CIVIQ-20
timeFrame: 12 months
measure: Clinical Change as Per VCSS
timeFrame: 12 months
measure: Pain Score Over the First 10 Days
timeFrame: For the first 10 days since procedure
measure: Degree of Bruising at 2 Weeks
timeFrame: 2 weeks
measure: Time to Return to Normal Activities
timeFrame: 2 weeks
measure: Occlusion Rates
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital, Imperial College London
Study officials:
affiliation: Imperial College London
name: Alun H Davies
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH. Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence: The MOCCA Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):395-404. doi: 10.1001/jamasurg.2022.0298.
citation: Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH. Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial. Trials. 2018 Aug 7;19(1):428. doi: 10.1186/s13063-018-2807-0.