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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07629843
Acronym
IPV-1940
Enrollment
155
Registered
2026-06-05
Start date
2026-09-01
Completion date
2028-06-01
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Saphenous Vein Injury

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.

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

PROCEDUREEndovenous 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.

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER
Euraxi Pharma
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Venous Treatment Satisfaction Questionnaire early score12 daysEvaluate 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).

Countries

France

Contacts

CONTACTClaudine HAMEL-DESNOS, MD
claudine.hamel-desnos@wanadoo.fr144085838

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026