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Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

NCT03270384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-11-26

No results posted yet for this study

Summary

The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.

Conditions

  • Urethral Stricture

Interventions

DEVICE

Urotronic Drug Coated Balloon (DCB)

The Urotronic 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

  • Sean Elliott, MD · University of Minnesota

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2019-11-01
Completion
2025-02-19
FDA Device
Yes

Countries

  • United States

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 NCT03270384 on ClinicalTrials.gov