Skip to main content
OpenTrials
Completed

NCT Number: NCT03392753

Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charing Cross Hospital, Imperial College London

London, W6 8RF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanochemical ablation

Procedure

Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)

Cyanoacrylate adhesive

Procedure

Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Clinical Change as Per VCSS

    Time frame: 12 months

    Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)

  6. 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.

  7. 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.

  8. Time to Return to Normal Activities

    Time frame: 2 weeks

    Length of time in days until normal activities are resumed

  9. Occlusion Rates

    Time frame: 12 months

    Rate of occlusion as assessed by duplex ultrasound

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Singapore General Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Jan 8, 2018
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.