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Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy
Sponsor: Assistance Publique Hopitaux De Marseille
Summary
SURF is a randomised controlled, parallel group, single blind phase II study designed to assess the safety and potential efficacy of an innovative therapeutic strategy for urethral stenosis based on adjuvant injection of autologous Adipose-Derived Stromal Vascular Fraction of Adipose Tissue (ADSVF) during endoscopic urethrotomy (standard care).
Official title: Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy: Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-03-13
Completion Date
2028-04
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
lipoaspiration
The surgeon will perform lipoaspiration under local anesthesia for the ADSVF production.
urethrotomy
The urologist will perform an endoscopic urethrotomy (standard care).
autologous ADSVF administration
ADSVF will be administrated in fibrotic lesion during urethrotomy by the urologist.
Locations (1)
Assistance Publique Hopitaux de Marseille
Marseille, France