Clinical trials: Urethra Stenosis
Urethral Stricture
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).
- Trial name
- ROBUST-III (NCT03499964)
- Testing
- Optilume Drug Coated Balloon (DCB), Control Treatment
- Where
- 22 sites in United States, Canada
- Volunteers
- 127 people
- Sponsor
- Urotronic Inc.
Urethral Stricture Less Than 2 cm
Treatment of Urethral Stricture With Urethral Drug Ball
To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture.
- Trial name
- NCT05812482
- Testing
- Drug balloon dilatation, Direct vision internal urethrotomy (DVIU)
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Urethral Stricture, Urethral Stricture, Anterior
Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study
The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment of urethral stricture.
- Conditions
- Urethral Stricture, Urethral Stricture, Anterior, Lower Urinary Tract Symptoms, Anterior Urethral Stricture
- Trial name
- ROBUST IV (NCT03851952)
- Testing
- Optilume Drug Coated Balloon
- Sponsor
- Urotronic Inc.
Urethral Stricture
Memokath® 044TW Stent for Treatment of Urethral Stricture
The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first…
- Trial name
- NCT00270504
- Testing
- Memokath stenting
- Where
- 7 sites in United States
- Volunteers
- 92 people
- Sponsor
- Pnn Medical DK
Urethral Stricture
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
- Trial name
- STREAM (NCT05383274)
- Testing
- Optilume Urethral DCB
- Where
- 9 sites in United States
- Volunteers
- 34 people
- Sponsor
- Urotronic Inc.
Urethral Stricture
Bioengineered Collagen Implant for Urethral Stricture Repair
The field of research for this study is tissue engineering and the utilization of a bioengineered collagen implant as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of distal urethral…
- Trial name
- NCT05463991
- Testing
- Bioengineered collagen implant
- Where
- Malaysia
- Volunteers
- 5 people
- Sponsor
- Regenosca SA
Stricture Urethra
ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
- Trial name
- ROBUST (NCT03014726)
- Testing
- Urotronic Drug Coated Balloon (DCB)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Urotronic Inc.
Urethral Stricture
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.
- Trial name
- ROBUST-II (NCT03270384)
- Testing
- Urotronic Drug Coated Balloon (DCB)
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- Urotronic Inc.
Genitourinary Anatomy
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
This prospective clinical study will evaluate the feasibility, performance, and safety of the LambdaGuide System for obtaining point-to-point measurements of observable genitourinary anatomy during cystoscopic procedures in adult…
- Trial name
- NCT07912385
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Lambda Surgical, Inc