RecruitingPhase 2NCT05857371

Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy

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

Sponsor

Assistance Publique Hopitaux De Marseille

Enrollment

20 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Urethral Stenosis

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).

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called autologous ADSVF administration, a procedure called lipoaspiration, and others for people with urethral stenosis. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURElipoaspiration

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

PROCEDUREurethrotomy

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

DRUGautologous ADSVF administration

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

Locations(1)

Assistance Publique Hopitaux de Marseille

Marseille, France

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NCT05857371