clinical trial · NCT05479422
Optilume Registry for Treatment of Stricture of the Anterior Urethra
European Association of Urology Research Foundation·—·active not recruiting·n = 150
Anterior Urethral Stricture, Male
brief 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.
started
Oct 13, 2022
primary completion
Aug 15, 2029
completion
Aug 15, 2029
last updated
Feb 24, 2025
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.
official title
European Clinical Registry for Optilume Urethral Drug Coated Balloon
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol