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RECRUITING
NCT05857371
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

lipoaspiration

The surgeon will perform lipoaspiration under local anesthesia for the ADSVF production.

PROCEDURE

urethrotomy

The urologist will perform an endoscopic urethrotomy (standard care).

DRUG

autologous ADSVF administration

ADSVF will be administrated in fibrotic lesion during urethrotomy by the urologist.

Locations (1)

Assistance Publique Hopitaux de Marseille

Marseille, France