Trials / Withdrawn
WithdrawnNCT03851952
Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Urotronic Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment of urethral stricture.
Conditions
- Urethral Stricture
- Urethral Stricture, Anterior
- Lower Urinary Tract Symptoms
- Anterior Urethral Stricture
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Optilume Drug Coated Balloon | 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. |
Timeline
- Start date
- 2019-05-31
- Primary completion
- 2020-10-31
- Completion
- 2024-12-31
- First posted
- 2019-02-22
- Last updated
- 2019-07-12
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03851952. Inclusion in this directory is not an endorsement.