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

NCT07629843 — Recruiting, 155 participants, GCS Ramsay Santé pour l'Enseignement et la Recherche

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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

RegistryNCT07629843, acronym IPV-1940
StatusRecruiting
Study typeObservational
Enrollment155 (Estimated)
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche (Other); collaborators: Euraxi Pharma
ConditionsSaphenous Vein Injury
InterventionsEndovenous laser ablation of the primary or recurrent saphenous vein (Procedure)
Datesstart 2026-10-01, primary completion 2028-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2026-06-05, last updated 2026-10-16
Locations2 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

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Primary or recurrent saphenous veinProcedure: Endovenous laser ablation of the primary or recurrent saphenous veinPatients receiving routine care for endovenous laser ablation of the primary or recurrent saphenous vein (great saphenous vein, small saphenous vein or anterior saphenous vein)
  • 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.

+Outcome measures

Primary outcomes

  • Venous Treatment Satisfaction Questionnaire early score [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).

+Eligibility

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).

+Locations (2)

FacilityCityCountryStatus
Institut de Pathologie Vasculaire - Hôpital Privé Geoffroy Saint-HilaireParisFranceRecruiting
Clinique de la MuetteParisFranceRecruiting