At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 53 enrolled
Drug / intervention
Urotronic Drug Coated Balloon (DCB)combination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
In Brief
A Early Phase 1 clinical trial evaluating Urotronic Drug Coated Balloon (DCB) for Stricture Urethra. Completed, enrolled 53 participants across 1 site.
Detailed Summary
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStricture Urethra
CountriesUnited States
Collaborators--
Timeline
Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedJan 2017
Primary CompletionOct 2018
Study CompletionApr 2023
TodayJul 2026
First PostedJan 9, 2017
Enrollment StartNov 1, 2016
Primary CompletionOct 1, 2018
Study CompletionApr 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.5 years ago
Interventions
Urotronic Drug Coated Balloon (DCB)combination
Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.