Actively Recruiting
Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy
Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-04
20
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Male aged 18 to 85 years
- Bulbar urethral stenosis 3 cm or less in length
- At least one urethral dilatation or urethrotomy for bulbar stenosis in the past 24 months
- Ability to avoid corticosteroids or immunosuppressive drugs for one month after treatment with physician approval if needed
- Good general health based on medical history and physical exam
- Body mass index (BMI) greater than 18 to allow fat tissue harvesting
You will not qualify if you...
- Urethral stenosis outside the bulbar region
- Urethral stenosis longer than 3 cm
- Urethral stenosis on reconstructed penis (e.g., transgender, post amputation)
- Previous perineal or pelvic radiotherapy
- Untreated urinary tract infection or perineal infection
- Penile cancer within the last 5 years
- Severe, uncontrolled, or progressive infectious, hepatic, hematological, gastrointestinal (except Crohn's disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
- Congenital or acquired immunodeficiencies
- Contraindications to anesthesia or surgery
- Use of corticosteroids or immunosuppressive drugs for more than 3 months
- Active viral infections including HIV, HTLV I and II, hepatitis B and C, or syphilis
- Administrative restrictions on participation
- Signs of obstructive voiding symptoms not caused by the stricture
- Untreated benign prostatic hyperplasia (BPH) or bladder neck contracture (BNC)
- Diagnosis of urethra, bladder, or prostate cancer within the last 2 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Assistance Publique Hopitaux de Marseille
Marseille, France
Actively Recruiting
Research Team
G
Gilles Karsenty, Pr.
CONTACT
A
Alexandra GIULIANI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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