ROBUST I Pilot Study (ROBUST)
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|ClinicalTrials.gov Identifier: NCT03014726|
Recruitment Status : Active, not recruiting
First Posted : January 9, 2017
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stricture Urethra||Device: Urotronic Drug Coated Balloon (DCB)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||December 2022|
Experimental: DCB Treatment
Stricture patients treated by DCB
Device: Urotronic Drug Coated Balloon (DCB)
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.
- Rate of Treatment Related Serious Complication [ Time Frame: 90 days post-procedure ]Device related formation of fistula; Device related de novo severe urinary retention
- Stricture Recurrence Rate [ Time Frame: 90 days post-procedure ]Improvement in IPSS (International Prostate Symptoms Score)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014726
|United States, Minnesota|
|Libra Medical Inc|
|Brooklyn Park, Minnesota, United States, 55428|