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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

NCT05857371 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-04

No results posted yet for this study

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).

Conditions

  • Urethral Stenosis

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.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • FRANCOIX CREMIEUX · ASSISITANCE PUBLIQUE HOPITAUX DE MARSEILLE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2027-11-30
Completion
2028-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857371 on ClinicalTrials.gov