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NCT03499964 · ClinicalTrials.gov registry record · NA
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
A NA study of Urethral Stricture, sponsored by Urotronic.
- Active
- Registry status
- NA
- Development phase
- 127
- Enrollment target
- 20
- Study locations
NCT03499964: Active NA study of Urethral Stricture, sponsored by Urotronic.
NCT03499964 is a NA study of Urethral Stricture that is active but no longer recruiting, run by Urotronic. The registered enrollment target is 127 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03499964, a NA study of Urethral Stricture, is active but no longer recruiting, sponsored by Urotronic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 127 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
The percentage of subjects deemed to be stricture free will be compared between arms. Stricture free subjects are those for which a 16F flexible cystoscope or 14F Foley catheter is able to be passed through the treated stricture without significant resistance.
Conditions Studied
Interventions
- DEVICE Optilume Drug Coated Balloon (DCB)
- DEVICE Control Treatment
Study Locations (20)
New York
- Western New York Urology Associates - Cheektowaga
- Columbia University Medical Center/New York-Presbyterian Hospital - New York
- Iris Cantor Men's Health Center - New York
- Integrated Medical Professionals OBP - North Hills
Minnesota
- University of Minnesota Department of Urology - Minneapolis
- Mayo Clinic - Rochester
- Minnesota Urology - Woodbury
Maryland
- Chesapeake Urology Research - Annapolis
- Chesapeake Urology - Hanover
Texas
- UT Southwestern - Dallas
- Urology San Antonio - San Antonio
Arizona
- Academic Urology and Urogynecology of Arizona - Phoenix
Arkansas
- Arkansas Urology - Little Rock
Florida
- Advanced Urology Institute - Daytona Beach
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2018-06-22 |
| Est. Completion | 2026-03 |
| Phase | NA |
What the registry record for NCT03499964 still lists
NCT03499964 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Urethral Stricture appearing as the primary indexed condition, and to 2 interventions - of which Optilume Drug Coated Balloon (DCB) is the first listed.
NCT03499964 names 20 study sites across 13 states, led by New York, Minnesota, Maryland.
Frequently Asked Questions
What is clinical trial NCT03499964 about?
NCT03499964 is a clinical study titled "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).
What is the current status of trial NCT03499964?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 127 participants. The study started on 2018-06-22. Estimated completion is 2026-03.
What conditions does trial NCT03499964 study?
This clinical trial studies the following conditions: Urethral Stricture.
What interventions are being tested in trial NCT03499964?
The interventions under investigation include: Optilume Drug Coated Balloon (DCB) (DEVICE), Control Treatment (DEVICE).
Who is sponsoring clinical trial NCT03499964?
This trial is sponsored by Urotronic, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03499964 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Florida, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Urethral Stricture
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03499964's enrollment target sits among peer trials
127 749th of 2000 higher than 1,252 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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