Efficacy of the ClariVein device for the treatment of varicose veins : a dose finding study.
- Conditions
- Incompetence of the great saphenous vein.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-003727-35-NL
- Lead Sponsor
- MUMC +
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
Patients with primary incompetence of the great saphenous vein, proven with duplex ultrasound examination and CEAP classification C2-C4.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600
Age < 18 years and or incompetent.
Life expectancy of less than 6 months
Previous surgery for GSV incompetence
Expected loss to follow-up
History of deep venous thrombosis
Occlusion of deep venous system
Pregnancy
No informed consent
Extreme obesity: BMI> 40
Very tortuous pace of GSV which bends at an angle of <90 º or more twists follow each other
Allergy or contraindication to Polidocanol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method