The ClariVein device using 2% and 3% liquid Polidocanol for the treatment of great saphenous vein incompetence

Phase 4

Completed

Conditions: varicose
10057165
10003184
great saphenous vein incompetence

Registration Number: NL-OMON39574

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

1) Patients who are first time treated for incompetence of the VSM, proven with duplex ultrasound examination.
2) CEAP classification C2-C4
3) All patients with informed consent.

Exclusion Criteria

1) Age < 18 years and or incompetent.
2) Life expectancy of less than 6 months
3) Previous surgery for GSV incompetence
4) Occlusion of deep venous system
5) Pregnancy
6) No informed consent
7) Extreme obesity: BMI> 40
8) Very tortuous pace of GSV which bends at an angle of <90 º or more twists follow each other
9) Allergy or contraindication to Polidocanol
10) GSV diameter bigger than 12mm.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary endpoint is the anatomical success rate of the treated GSV after 6<br /><br>months, defined as occlusion confirmed by ultrasound of at least 85% which<br /><br>correlates to 25,5cm of the treated 30cm.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Mean VCSS change (evaluated at mentioned time points).<br /><br>Pain score during procedure (VAS)<br /><br>Two weeks post-preocedure pain score (VAS)<br /><br>Health status (using the SF36 the general health status will be evaluated at<br /><br>mentioned time points).<br /><br>Disease related quality of life (using the AVVQ, the quality of life related to<br /><br>the disease will be evaluated at mentioned time points).<br /><br>Adverse events<br /><br>Patient satisfaction measured in separate scores.</p><br>