NCT03499964

ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Urotronic Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).

Detailed description

ROBUST III is a prospective, multi-center, single blind randomized controlled clinical trial in a 2:1 allocation of treatment versus control device. This study is an adaptive design with an interim analysis for sample size re-estimation performed after 60 subjects have been enrolled. The interim analysis will be be undertaken following completion of the 6-month follow-up data from these subjects. Based on the results of the interim analysis, the final total sample size required for the study will be re-estimated. A minimum of 140 subjects, and a maximum of 200 subjects (pending the re-estimation) will be enrolled in the study. A Data Monitoring Committee (DMC) will review the interim analysis results, including the sample size re-estimation and make recommendations related to trial continuation to the sponsor.

Conditions

• Urethral Stricture

Interventions

Type	Name	Description
DEVICE	Optilume Drug Coated Balloon (DCB)	The Optilume 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.
DEVICE	Control Treatment	A control subject may be dilated with either a rod, uncoated balloon or DVIU until the desired result is reached, based on standard of care for the clinical site and treating physician

Timeline

• Start date: 2018-06-22
• Primary completion: 2020-12-10
• Completion: 2026-03-01
• First posted: 2018-04-17
• Last updated: 2025-10-15
• Results posted: 2023-06-06

Locations

22 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study