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Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study

NCT03851952 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-07-12

No results posted yet for this study

Summary

The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment of urethral stricture.

Conditions

  • Urethral Stricture
  • Urethral Stricture, Anterior
  • Lower Urinary Tract Symptoms
  • Anterior Urethral Stricture

Interventions

DEVICE

Optilume Drug Coated Balloon

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.

Sponsors & Collaborators

  • Urotronic Inc.

    lead INDUSTRY

Principal Investigators

  • Ron Kodama, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2020-10-31
Completion
2024-12-31
FDA Device
Yes

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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 NCT03851952 on ClinicalTrials.gov