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Active, not recruiting Not applicable Interventional Results available

ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

ClinicalTrials.gov ID: NCT03499964

Public ClinicalTrials.gov record NCT03499964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:59 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03499964
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Urotronic Inc.
Industry
Enrollment
127 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 22, 2018 (Actual)
Primary completion
Dec 10, 2020 (Actual)
Completion
Aug 2026 (Estimated)
Last update posted
May 19, 2026

2018 – 2026

United States locations

U.S. sites
21
U.S. states
14
U.S. cities
20
Facility City State ZIP Site status
Academic Urology and Urogynecology of Arizona Phoenix Arizona 85027 —
Arkansas Urology Little Rock Arkansas 72211 —
Advanced Urology Institute Daytona Beach Florida 32114 —
University of Iowa Iowa City Iowa 52242 —
Chesapeake Urology Research Annapolis Maryland 21401 —
Chesapeake Urology Hanover Maryland 21076 —
University of Minnesota Department of Urology Minneapolis Minnesota 55445 —
Mayo Clinic Rochester Minnesota 55905 —
Minnesota Urology Woodbury Minnesota 55125 —
Adult & Pediatric Urology, PC Omana Nebraska 68114 —
New Jersey Urology Voorhees Township New Jersey 08043 —
Western New York Urology Associates Cheektowaga New York 14225 —
Columbia University Medical Center/New York-Presbyterian Hospital New York New York 10032 —
Iris Cantor Men's Health Center New York New York 10065 —
Integrated Medical Professionals OBP North Hills New York 11042 —
Carolina Urology Partners Concord North Carolina 28025 —
Oregon Urology Institute Springfield Oregon 97477 —
UT Southwestern Dallas Texas 75390 —
Urology San Antonio San Antonio Texas 78229 —
Urology of Virginia Virginia Beach Virginia 23462 —
University of Washington Harborview Medical Center Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03499964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 19, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03499964 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →