NCT02012036

Study To Optimize Photodynamic Transurethral Resection of the Bladder (TUR-B) In Clinical Practice

OPTIC-III Prospective Non-Interventional Study To Optimize Photodynamic TUR-B In Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical practice.

Conditions

• Photodynamic Transurethral Resection of the Bladder (TUR-B)

Interventions

Type	Name	Description
DRUG	Hexvix	As this is a non-interventional study, detection of NMIBC with Hexvix is in a pre-defined group, chosen prior to and independently from the decision to enrol the subject in this study. The detection with Hexvix should be in accordance with local Summary of Product Characteristics \[SmPC\]. Subjects will be treated in accordance with usual medical practice during their participation in this study, no additional assessment or tests will be required.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-12-16
• Last updated: 2019-08-16

Locations

2 sites across 1 country: Germany