- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014726
ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (ROBUST)
ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is designed to determine the safety and effectiveness for drug coated balloon (DCB).
Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Minnesota
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Brooklyn Park, Minnesota, United States, 55428
- Libra Medical Inc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male subjects ≥ 18 years' old
- Visual confirmation of stricture via cystoscopy or urethrogram
- Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm
- One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty
- Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's.
- IPSS score of 13 or higher
- Lumen diameter <12F by urethrogram
- Able to complete validated questionnaire independently
- Qmax <10 ml/sec
Exclusion Criteria:
- Strictures greater than 2.0 cm long.
- Subjects that have more than 1 stricture.
- Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
- Subjects who have a suprapubic catheter and are unable to complete study required testing, such as uroflowmetry
- Previous urethroplasty within the anterior urethra
- Stricture due to bacterial urethritis or untreated gonorrhea
- Stricture dilated or incised within the last 3 months
- Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.
- Presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as BPH at the discretion of the clinical investigator
- Previous radical prostatectomy
- Previous pelvic radiation
- Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
- Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL
- Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.)
- Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DCB Treatment
Stricture patients treated by DCB
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Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip.
The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Treatment Related Serious Complication
Time Frame: 90 days post-procedure
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|
90 days post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stricture Recurrence Rate
Time Frame: 90 days post-procedure
|
|
90 days post-procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ian Schorn, Urotronic (Study Sponsor)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSC016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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