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

NCT05600322 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2024-10-03

Study results available
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Summary

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

Conditions

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.

Sponsors & Collaborators

  • Jiangsu Yahong Meditech Co., Ltd aka Asieris

    collaborator INDUSTRY

  • Richard Wolf GmbH

    collaborator INDUSTRY

  • Tigermed-Jyton Co., Ltd.

    collaborator INDUSTRY

  • Photocure

    lead INDUSTRY

Principal Investigators

  • Li Han Zhong, BMed · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2023-07-12
Completion
2023-07-12

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05600322 on ClinicalTrials.gov