Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (ROBUST-II)

November 21, 2022 updated by: Urotronic Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Chesapeake Urology
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Metro Urology
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male subjects ≥ 18 years' old
  2. Visual confirmation of stricture via cystoscopy or urethrogram
  3. Single lesion anterior urethral stricture less than or equal to 3 cm
  4. Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty
  5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections).
  6. IPSS (International Prostate Symptom Score) score of 13 or higher
  7. Lumen diameter <12F by urethrogram
  8. Able to complete validated questionnaire independently
  9. Qmax <12 ml/sec
  10. Guidewire must be able to cross the lesion

Exclusion Criteria:

  1. Strictures greater than 3.0 cm long.
  2. Subjects that have more than 1 stricture.
  3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
  4. Subjects who have a suprapubic catheter
  5. Previous urethroplasty within the anterior urethra
  6. Stricture due to bacterial urethritis or untreated gonorrhea
  7. Stricture dilated or incised within the last 3 months
  8. History of over active bladder or stress incontinence
  9. Previous radical prostatectomy
  10. Previous pelvic radiation
  11. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
  12. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
  13. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety- Rate of Device Related Serious Complications
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety- Change in IIEF (International Index of Erectile Function)
Time Frame: 90 days
90 days
Efficacy- Stricture Recurrence Rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urotronic Inc.

Investigators

  • Principal Investigator: Sean Elliott, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 21, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR1032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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