NCT03014726

ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Urotronic Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.

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.

Conditions

• Stricture Urethra

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-10-01
• Completion: 2023-04-01
• First posted: 2017-01-09
• Last updated: 2024-03-22
• Results posted: 2024-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study