Trials / Active Not Recruiting
Active Not RecruitingNCT05479422
Optilume Registry for Treatment of Stricture of the Anterior Urethra
European Clinical Registry for Optilume Urethral Drug Coated Balloon
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- European Association of Urology Research Foundation · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this registry is verifying the continued safety and effectiveness of the Optilume DCB clinical use in patients undergoing dilation of the urethral stricture.
Detailed description
After being informed about the registry and potential risks, all patients providing written informed consent will undergo urethral dilation using the Optilume Drug Coated Balloon (standard of care procedure). At 3, 6, 12 months, and annually 2 to 5 years after treatment patients will be invited to return to the hospital and several assessments will be performed, including questionnaires, if this is part of their standard care.
Conditions
Timeline
- Start date
- 2022-10-13
- Primary completion
- 2029-08-15
- Completion
- 2029-08-15
- First posted
- 2022-07-29
- Last updated
- 2025-02-24
Locations
13 sites across 5 countries: Belgium, Italy, Norway, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT05479422. Inclusion in this directory is not an endorsement.