Patient Satisfaction, Safety and Efficacy of Treatment for Saphenous Veins and Varicose Veins Outside the Operating Theater Under Strict Local Anesthesia With 1940nm Endovenous Laser: a Prospective Multicenter Observational Study
| Registry | NCT07629843, acronym IPV-1940 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 155 (Estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche (Other); collaborators: Euraxi Pharma |
| Conditions | Saphenous Vein Injury |
| Interventions | Endovenous laser ablation of the primary or recurrent saphenous vein (Procedure) |
| Dates | start 2026-10-01, primary completion 2028-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2026-06-05, last updated 2026-10-16 |
| Locations | 2 sites in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Saphenous Vein Injury All trials of Endovenous laser ablation of the primary or recurrent saphenous vein
The purpose of this study is to evaluate the post-operative patient satisfaction on the treatment of saphenous veins and varicose veins outside the operating theater under strict local anesthesia with a 1940 nm laser via the Venous Treatment Satisfaction Questionnaire early.
This is a non-interventional, prospective, non-randomized, descriptive, and multicenter study.
The study will be conducted by vascular physicians practicing at the Institute of Vascular Pathology of the Geoffroy Saint-Hilaire Private Hospital or La Muette Clinic (Paris).
The study population will be composed of adult patients receiving routine care for Endovenous Laser Ablation of primary or recurrent saphenous vein (great saphenous vein, small saphenous vein or anterior saphenous vein) outside the operating theater under strict local anesthesia.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Primary or recurrent saphenous vein | Procedure: Endovenous laser ablation of the primary or recurrent saphenous vein | Patients receiving routine care for endovenous laser ablation of the primary or recurrent saphenous vein (great saphenous vein, small saphenous vein or anterior saphenous vein) |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age ≥ 18 years. * Endovenous Laser Ablation of a common or recurrent saphenous vein as part of routine care. * Clinical, Etiology, Anatomy, Pathophysiology, classification clinical stage. * Ability to understand the study objectives and complete questionnaires in French. * Patient has been informed and has verbally indicated their non-opposition to participating in the research. Exclusion Criteria: * Endovenous Laser Ablation not feasible for technical reasons, particularly if the vein is too "bent" or there are endoluminal obstacles. * Episode of deep vein thrombosis less than 3 months ago or of superficial vein thrombosis less than 6 weeks ago. * Active cancer. * Geographical distance incompatible with study follow-up, according to the investigator's judgment. * Patients currently participating or having participated in research within the previous 3 months. * Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponds to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
| Facility | City | Country | Status |
|---|---|---|---|
| Institut de Pathologie Vasculaire - Hôpital Privé Geoffroy Saint-Hilaire | Paris | France | Recruiting |
| Clinique de la Muette | Paris | France | Recruiting |