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NCT Number: NCT07629843

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Pathologie Vasculaire - Hôpital Privé Geoffroy Saint-Hilaire

Paris, 75005, France

Location contact

Claudine HAMEL-DESNOS, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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 outcomes

  1. Venous Treatment Satisfaction Questionnaire early score

    Time frame: 12 days

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Claudine HAMEL-DESNOS, MD

CONTACT

[email protected]

144085838 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study 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

Acronym: IPV-1940

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.