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

PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

November 3, 2022

Primary Completion Date

July 12, 2023

Study Completion Date

July 12, 2023

Conditions
Bladder Cancer
Interventions
DRUG

Hexaminolevulinate Hydrochloride

Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.

DEVICE

Richard Wolf Photodynamic Diagnostic Equipment (PDD) system

Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.

Trial Locations (7)

Unknown

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing

Peking University Third Hospital, Beijing

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

Wuhan University People's Hospital, Wuhan

Hunan Cancer Hospital, Changsha

Zhongshan Hospital, Fudan University, Shanghai

The Second Hospital of Tianjin Medical University, Tianjin

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Jiangsu Yahong Meditech Co., Ltd aka Asieris

INDUSTRY

collaborator

Richard Wolf GmbH

INDUSTRY

collaborator

Tigermed-Jyton Co., Ltd.

INDUSTRY

lead

Photocure

INDUSTRY