NCT00348764

ESGVS: Sclerotherapy With Lauromacrogol

Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam -Comparative Study of 3% Versus 1% Concentration.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol 400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study of 3% versus 1% Lauromacrogol 400 foam.

Detailed description

A multicenter randomized double blind study to evaluate the efficacy and the tolerance of echoguided sclerotherapy using 3% versus 1% Lauromacrogol 400 foam in the treatment of Great Saphenous Vein (GSV) insufficiency. One hundred fifty eligible patients will be recruited during 6 months from 9 study centers with a follow up period of 3 years and 7 visits at day 8, 6 weeks, 3 months, 6 months, 1,2 ,and 3 years. After randomization, the patients will be treated by echoguided sclerotherapy with 1% or 3% Lauromacrogol 400 foam (ratio 1:1). Monitoring is performed by doppler at 8 days, 6 weeks, 6 months , 1,2 ,and 3 years. Effectiveness of sclerotherapy is determined at 6 weeks, 3 months and 6 months. A additional injection of 4 ml of foam can be performed if needed. Severity clinical score and Quality-of-life questionnaire are performed at 6 months ,1 ,2, and 3 years. The absence of obliteration with a reflux of crural great saphenous vein at 6 months will be a criterion of therapeutic failure. The therapeutic success or failure criteria are evaluated by a non investigator angiologist for 5 patients randomized from each investigational site at 1, 2 and 3 years.

Conditions

• Venous Insufficiency
• Saphenous Vein

Interventions

Type	Name	Description
DRUG	lauromacrogol

Timeline

• Start date: 2004-03-01
• Completion: 2006-12-01
• First posted: 2006-07-06
• Last updated: 2006-07-06

Locations

1 site across 1 country: France