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A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting

NCT02560584 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2018-07-02

Study results available
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Summary

The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.

Conditions

Interventions

DRUG

Hexaminolevulinate hydrochloride

Instillation in bladder

DEVICE

KARL STORZ D-Light C PDD Flexible Videoscope System

Cystoscopy procedure

Sponsors & Collaborators

  • KARL STORZ Endoscopy-America, Inc.

    collaborator INDUSTRY

  • Photocure

    lead INDUSTRY

Principal Investigators

  • Mark Schoenberg, MD · Montefiore Medical Center

  • J. Stephen Jones, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2017-04-05
Completion
2017-04-05

Countries

  • United States

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 NCT02560584 on ClinicalTrials.gov