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Tests treatment safety and results for Urethral Stenosis
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
ClinicalTrials.gov ID: NCT05857371
What this study is testing
What is autologous ADSVF administration?
autologous ADSVF administration is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for urethral stenosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85, men only
You may be able to join if
- Signed informed consent
- Male, aged from 18 to 85 years
- Bulbar urethral stenosis ≤ 3 cm.
- At least one urethral dilatation or urethrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis
- Ability to avoid corticoids or immunosuppressive drugs one month after treatment. For any patients with either corticoid or immunosuppressive...
You likely can't join if
- Urethral stenosis of other location than bulbar
- Urethral stenosis length \> 3 cm
- Urethral stenosis on reconstructed penis (transgender, post amputation)
- Prior perineal or pelvic radiotherapy
- Concurrent urinary tract infection without treatment
- Concurrent perineal infection
See the full eligibility criteria
- Signed informed consent
- Male, aged from 18 to 85 years
- Bulbar urethral stenosis ≤ 3 cm.
- At least one urethral dilatation or urethrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis
- Ability to avoid corticoids or immunosuppressive drugs one month after treatment. For any patients with either corticoid or immunosuppressive treatment the physician in charge of this treatment will be contacted and...
- Good general health status according to clinical history and a physical examination
- BMI \> 18 to insure adequate access to abdominal or other subcutaneous adipose tissue for adipose tissue harvesting
- Urethral stenosis of other location than bulbar
- Urethral stenosis length \> 3 cm
- Urethral stenosis on reconstructed penis (transgender, post amputation)
- Prior perineal or pelvic radiotherapy
- Concurrent urinary tract infection without treatment
- Concurrent perineal infection
- Penile cancer \< 5 years
- Current or recent history of abnormal, severe, progressive, uncontrolled infectious, hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease
- Congenital or acquired immunodeficiencies
- Contraindication to the anaesthetic or surgical procedure
- Corticoids or immunosuppressive drugs \> 3 months
- Any active viral infection among the following: HIV, HTLV I and II, VHB, VHC and syphillis
- Administrative restricted rights
- Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician
- Diagnosis of untreated and unresolved BPH benign prostatic hyperplasia or BNC bladder neck contracture
- Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.