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Device
Urotronic Drug Coated Balloon (DCB) for Urethral Stricture (ROBUST Trial)
Phase < 1
Waitlist Available
Research Sponsored by Urotronic Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post-procedure
Awards & highlights
ROBUST Trial Summary
This trial is testing whether a drug-coated balloon is safe and effective for treating blocked arteries.
Eligible Conditions
- Urethral Stricture
ROBUST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Treatment Related Serious Complication
Secondary outcome measures
Stricture Recurrence Rate
ROBUST Trial Design
1Treatment groups
Experimental Treatment
Group I: DCB TreatmentExperimental Treatment1 Intervention
Stricture patients treated by DCB
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Urotronic Drug Coated Balloon (DCB)
2016
Completed Early Phase 1
~60
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Who is running the clinical trial?
Urotronic Inc.Lead Sponsor
8 Previous Clinical Trials
879 Total Patients Enrolled
4 Trials studying Urethral Stricture
177 Patients Enrolled for Urethral Stricture
Ian SchornStudy DirectorUrotronic (Study Sponsor)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for volunteers to participate in this clinical research?
"Clinicaltrials.gov specifies that this trial is no longer recruiting participants, though it was initially posted on November 1st 2016 and updated as recently as April 26th 2021. However, there are 218 other medical studies in progress actively searching for patients at present."
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