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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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5 June 2017 |
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Main ID: |
ISRCTN06552809 |
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Date of registration:
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16/08/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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VNUS vs ClariVein for varicose veins
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Scientific title:
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Randomised clinical trial comparing VNUS ClosureFAST with ClariVein for varicose veins |
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Date of first enrolment:
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22/01/2013 |
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Target sample size:
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170 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN06552809 |
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Study type:
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Interventional |
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Study design:
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Randomised clinical trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Alun
Davies |
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Address:
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Academic Section of Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
W6 8RF
London
United Kingdom |
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Telephone:
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- |
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Email:
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tristan.lane@imperial.ac.uk |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Adults over 18 years of age
2. Symptomatic long or short saphenous vein reflux < 0.5 seconds on colour duplex
Exclusion criteria: 1. Current DVT
2. Recurrent varicose veins
3. Arterial disease (ABPI <0.8)
4. Veins less than 3 mm in diameter
5. Hypercoagulability
6. Patients who are unwilling to participate
7. Inability or unwillingness to complete questionnaires
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Varicose veins, venous disease
Circulatory System
Varicose veins of other sites
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Intervention(s)
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Treatment arm one is:
VNUS ClosureFast radiofrequency ablation of the incompetent long or short saphenous vein with phlebectomies as per standard published treatment technique.
Treatment arm two is:
ClariVein mechanochemical ablation of the incompetent long or short saphenous vein with phlebectomies as per standard published treatment technique.
There is no medication utilised. The treatment if one sitting in an outpatient procedure.
Follow-up is 6 months in both arms.
Patients will be randomised to receive one of the possible treatment options. Treatments will be completed under local anaesthetic with concomitant phlebectomy if necessary. Randomisation will be via an internet randomisation service.
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Primary Outcome(s)
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1. A comparison of pain during the procedure measured using a patient-reported visual analogue score (VAS) comparing RFA and ClariVein®
2. Treatments will be performed under local anaesthetic with concomitant phlebectomy to treat varicosities
3. Pain during the procedure will be measured using a validated patient-reported Visual Analogue Score (VAS)
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Secondary Outcome(s)
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1. Quality of life at 30 days and 6 months measured using the Aberdeen Varicose Vein Severity Score (AVVSS)
2. Occlusion rates at 30 day and 6 months
3. Clinical success, including residual varicosities, complications and recurrence rates at 6 months
4. Improvements in generic quality of life using the EQ-5D at 30 days and 6 months
5. Clinical improvements measured using the Venous Clinical Severity Score (VCSS) at 30 days and 6 months
6. Time to return to work and normal activities assessed using a 30-day patient diary
7. A comparison of the cost-effectiveness of the treatment regimes will be made
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Source(s) of Monetary Support
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Vascular Insights (USA)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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