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Not yet recruiting NCT07629843

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

Observational Saphenous Vein Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endovenous laser ablation of the primary or recurrent saphenous vein.
Who it may be relevant to
Registry conditions: Saphenous Vein Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Venous Treatment Satisfaction Questionnaire early score [Time frame: 12 days]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Institut de Pathologie Vasculaire - Hôpital Privé Geoffroy Saint-Hilaire — Paris

Identifiers

NCT: NCT07629843 · 2026-A00763-48

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗