Patient Satisfaction, Safety, and Efficacy of Endovenous Laser Treatment for Saphenous Veins and Varicose Veins (IPV-1940)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Saphenous Vein Injury
• Intervention / Treatment: Procedure: Endovenous laser ablation of the primary or recurrent saphenous vein

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 155

Contacts and Locations

• Study Contact: Name: Claudine HAMEL-DESNOS, MD; Phone Number: +33 144085838; Email: claudine.hamel-desnos@wanadoo.fr

Study Locations

• France
  • Paris, France, 75005
    • Institut de Pathologie Vasculaire - Hôpital Privé Geoffroy Saint-Hilaire
    • Contact: Claudine HAMEL-DESNOS, MD; Email: claudine.hamel-desnos@wanadoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Procedure: Endovenous laser ablation of the primary or recurrent saphenous vein; Treatment of saphenous veins and varicose veins performed outside the operating room strictly under local anesthesia with a 1940 nm laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous Treatment Satisfaction Questionnaire early score	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.	12 days

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-A00763-48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No