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NCT03014726 · ClinicalTrials.gov registry record · Early Phase 1
ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
A Early Phase 1 study, sponsored by Urotronic.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 53
- Enrollment target
NCT03014726: Completed Early Phase 1 study, sponsored by Urotronic.
NCT03014726 is a Early Phase 1 study that has completed, run by Urotronic. The registered enrollment target is 53 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03014726, a Early Phase 1 study, has completed, sponsored by Urotronic.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
Primary Outcome
* urethral formation of fistula * de novo severe urinary retention lasting \> 14 consecutive days' post-treatment * unresolved de novo stress urinary incontinence (requiring \>1 pad/day) at 90 days or earlier * urethra rupture or burst.
Interventions
- COMBINATION_PRODUCT Urotronic Drug Coated Balloon (DCB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2016-11 |
| Est. Completion | 2023-04 |
| Phase | Early Phase 1 |
What the finished NCT03014726 record still lists
NCT03014726 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Urotronic Drug Coated Balloon (DCB) is the first listed.
NCT03014726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03014726 about?
NCT03014726 is a clinical study titled "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.
What is the current status of trial NCT03014726?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 53 participants. The study started on 2016-11. Estimated completion is 2023-04.
What interventions are being tested in trial NCT03014726?
The interventions under investigation include: Urotronic Drug Coated Balloon (DCB) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03014726?
This trial is sponsored by Urotronic, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03014726's enrollment target sits among peer trials
53 472nd of 2000 higher than 1,525 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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