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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03392753
Other study ID # 17/LO/1457
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 6, 2017
Est. completion date December 31, 2021

Study information

Verified date August 2022
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 167
Est. completion date December 31, 2021
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mechanochemical ablation
Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)
Cyanoacrylate adhesive
Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)

Locations

Country Name City State
United Kingdom Charing Cross Hospital, Imperial College London London

Sponsors (2)

Lead Sponsor Collaborator
Imperial College London Singapore General Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pain Score at the End of the Procedure 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
Secondary Generic Quality of Life as Per EQ-5D Questionnaire Using the EuroQoL's EQ-5D questionnaire (-0.085=worse quality of life; 1.000=best quality of life) Recorded at 12 months
Secondary Disease Specific Quality of Life as Per the AVVQ Using the Aberdeen Varicose Vein Questionnaire (AVVQ) questionnaire (0=best quality of life; 100=worse quality of life) Recorded at 12 months
Secondary Disease Specific Quality of Life as Per the CIVIQ-20 Using the CIVIQ-20 questionnaire (0=best quality of life; 100=worse quality of life) 12 months
Secondary Clinical Change as Per VCSS Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse) 12 months
Secondary Pain Score Over the First 10 Days 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
Secondary Degree of Bruising at 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
Secondary Time to Return to Normal Activities Length of time in days until normal activities are resumed 2 weeks
Secondary Occlusion Rates Rate of occlusion as assessed by duplex ultrasound 12 months
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