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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
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment Phase
Varicose Veins Procedure: Mechanochemical ablation Procedure: Cyanoacrylate adhesive Phase 4

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  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. Quality of life [ Time Frame: 12 months ]
    Using the EuroQoL's EQ-5D questionnaire

  3. Quality of life [ Time Frame: 12 months ]
    Using the Aberdeen Varicose Vein Questionnaire (AVVQ) questionnaire

  4. Quality of life [ Time Frame: 12 months ]
    Using the CIVIQ questionnaire

  5. Clinical change [ Time Frame: 12 months ]
    Using the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification

  6. Clinical change [ Time Frame: 12 months ]
    Using the Venous Clinical Severity Score (VCSS)

  7. 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)

  8. 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)

  9. Time to return to normal activities [ Time Frame: 2 weeks ]
  10. Occlusion rates [ Time Frame: 12 months ]
  11. Re-intervention rates [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Amjad Belramman 02033117335 a.belramman17@imperial.ac.uk
Contact: Roshan Bootun 02033117335 r.bootun@imperial.ac.uk

Locations
United Kingdom
Charing Cross Hospital, Imperial College London Recruiting
London, United Kingdom, W6 8RF
Contact: Amjad Belramman    +442033117335    a.belramman17@imperial.ac.uk   
Contact: Roshan Bootun    +442033117335    r.bootun@imperial.ac.uk   
Principal Investigator: Alun H Davies         
Sub-Investigator: Tristan RA Lane         
Sub-Investigator: Roshan Bootun         
Sub-Investigator: Amjad Belramman         
Principal Investigator: Tjun Y Tang         
Sponsors and Collaborators
Imperial College London
Singapore General Hospital
Investigators
Principal Investigator: Alun H Davies Imperial College London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03392753     History of Changes
Other Study ID Numbers: 17/LO/1457
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases