Stricture Urethra Clinical Trial
Official title:
ROBUST I Pilot Study, ROBUST I 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.
The study is designed to determine the safety and effectiveness for drug coated balloon (DCB). Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05678413 -
Role of Paclitaxel in Stricture Urethra
|
N/A |