Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

August 3, 2022 updated by: Imperial College London

Randomised Controlled Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital, Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
On day 0 immediately following vein ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
On day 0 following vein ablation and any tributary treatment
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)
Recorded at 12 months
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)
Recorded at 12 months
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)
12 months
Clinical Change as Per VCSS
Time Frame: 12 months
Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)
12 months
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.
For the first 10 days since procedure
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.
2 weeks
Time to Return to Normal Activities
Time Frame: 2 weeks
Length of time in days until normal activities are resumed
2 weeks
Occlusion Rates
Time Frame: 12 months
Rate of occlusion as assessed by duplex ultrasound
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Singapore General Hospital

Investigators

  • Principal Investigator: Alun H Davies, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2017

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/LO/1457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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