NCT03392753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

December 7, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

November 28, 2017

Results QC Date

September 23, 2021

Last Update Submit

August 3, 2022

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (1)

  • Pain Score During 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 Outcomes (9)

  • Pain Score at the End of the Procedure

    On day 0 following vein ablation and any tributary treatment

  • Generic Quality of Life as Per EQ-5D Questionnaire

    Recorded at 12 months

  • Disease Specific Quality of Life as Per the AVVQ

    Recorded at 12 months

  • Disease Specific Quality of Life as Per the CIVIQ-20

    12 months

  • Clinical Change as Per VCSS

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Mechanochemical ablation (MOCA)

ACTIVE COMPARATOR

Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).

Procedure: Mechanochemical ablation

Cyanoacrylate adhesive (CAE)

ACTIVE COMPARATOR

Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).

Procedure: Cyanoacrylate adhesive

Interventions

Mechanochemical ablationPROCEDURE

Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)

Mechanochemical ablation (MOCA)
Cyanoacrylate adhesivePROCEDURE

Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)

Cyanoacrylate adhesive (CAE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charing Cross Hospital, Imperial College London

London, W6 8RF, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 35385061DERIVED

  • 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.

    PMID: 30086774DERIVED

MeSH Terms

Conditions

Varicose Veins

Interventions

MK 6 cyanoacrylate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Mr Roshan Bootun
Organization
Imperial College London
r.bootun@imperial.ac.uk
+442033117335

Study Officials

  • Alun H Davies

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
An internet-based randomisation service will be used Outcome assessors will be blinded as to treatment offered
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

January 8, 2018

Study Start

November 6, 2017

Primary Completion

July 31, 2019

Study Completion

December 31, 2021

Last Updated

August 4, 2022

Results First Posted

December 7, 2021

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)