Patient Satisfaction, Safety, and Efficacy of Endovenous Laser Treatment for Saphenous Veins and Varicose Veins

NCT07629843 | Not Yet Recruiting

• 1 other identifier: 2026-A00763-48
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Saphenous Vein Injury

Outcome Measures

Primary Outcomes (1)

• 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. Scale from 0 to 6 (a high score indicates a positive result).

  12 days

Study Arms (1)

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

Interventions

Endovenous laser ablation of the primary or recurrent saphenous vein PROCEDURE

Treatment of saphenous veins and varicose veins performed outside the operating room strictly under local anesthesia with a 1940 nm laser.

Primary or recurrent saphenous vein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Euraxi Pharma: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Institut de Pathologie Vasculaire - Hôpital Privé Geoffroy Saint-Hilaire

Paris, 75005, France

Location

Central Study Contacts

Claudine HAMEL-DESNOS, MD

CONTACT

144085838; claudine.hamel-desnos@wanadoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

FR (1)