Trials / Completed
CompletedNCT03270384
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Urotronic Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Urotronic Drug Coated Balloon (DCB) | The Urotronic 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
- 2017-10-25
- Primary completion
- 2019-11-01
- Completion
- 2025-02-19
- First posted
- 2017-09-01
- Last updated
- 2025-11-26
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03270384. Inclusion in this directory is not an endorsement.