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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 is a NA study of Urethral Stricture that is active but no longer recruiting, run by Urotronic. The registered enrollment target is 127 participants. The trial reports 20 study locations across 13 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03499964
The ClinicalTrials.gov registry entry for NCT03499964 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Urotronic, which has 8 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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