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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.

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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

FieldValue
Enrollment Target 127 participants
Start Date 2018-06-22
Est. Completion 2026-03
Phase NA

Sponsor

Urotronic

8 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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