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Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

Bladder Cancer Clinical Trial

Official title:
A Prospective, Comparative Within Patient Controlled, Multi-center Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

Clinical Trial Summary

A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.

Clinical Trial Description

A phase III, prospective, within patient controlled, multi-center study to compare Blue light cystoscopy with Hexvix and standard White light cystoscopy in the detection of bladder cancer, to evaluate the efficacy and safety of Hexvix Blue light cystoscopy in Chinese population. Patients with suspicious or confirmed bladder cancer will participate in the trial and undergo Blue light cystoscopy with Hexvix in addition to the standard White light cystoscopy. Specific clinical questions will be asked: - What is the proportion of patients who have at least one specific kind of tumor found by Blue light cystoscopy with Hexvix but not by White light cystoscopy? - What is the proportion of patients who have at least one specific kind of lesion found by Blue light cystoscopy with Hexvix but not by White light cystoscopy? - What is the proportion of false positive lesions detected with Hexvix Blue light cystoscopy and White light cystoscopy? - What is the proportion of patients with Adverse Events (AE) during the study? ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05600322
Study type Interventional
Source Photocure
Contact
Status Completed
Phase Phase 3
Start date November 3, 2022
Completion date July 12, 2023
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