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

NCT03499964 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2026-05-19

Study results available
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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

  • Urethral Stricture

Interventions

DEVICE

Optilume Drug Coated Balloon (DCB)

The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.

DEVICE

Control Treatment

A control subject may be dilated with either a rod, uncoated balloon or DVIU until the desired result is reached, based on standard of care for the clinical site and treating physician

Sponsors & Collaborators

  • Laborie Medical Technologies Inc.

    collaborator INDUSTRY

  • NAMSA

    collaborator OTHER

  • Urotronic Inc.

    lead INDUSTRY

Principal Investigators

  • Sean Elliott, MD · University of Minnesota

  • Ramon Virasoro, MD · US Department of Veterans Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2020-12-10
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03499964 on ClinicalTrials.gov