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



Status:Completed
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/4/2018
Start Date:October 1, 2015
End Date:April 5, 2017

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A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer

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.


1. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be
included only at the first surveillance cystoscopy after a histologically confirmed
tumor. The histologically confirmed tumor could either be from a TURB or from a
surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by
histology)

2. History of one or more of the following:

- Multiple tumors

- Recurrent tumors

- High grade tumor(s)

Exclusion Criteria:

1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed
resulting in significant amounts of blood in the urine, which may visually limit
cystoscopy. Where the haematuria is light, the patient should not be excluded, if in
the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will
alleviate the haematuria limitations to cystoscopy)

2. Patients who cannot undergo in-office or operating room cystoscopy (Note: Training
patients are eligible even if they cannot undergo operating room cystoscopy)

3. Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or
intravesical chemotherapy within the past 6 weeks prior to the procedure

4. Porphyria

5. Known allergy to hexaminolevulinate hydrochloride or a similar compound

6. Pregnancy or breast-feeding (all women of child-bearing potential must document a
negative urine pregnancy test before study inclusion and use adequate contraception
during the study

7. Participation in other clinical studies with investigational drugs either concurrently
or within the last 30 days

8. Patient is the investigator or any sub investigator, research assistant, pharmacist,
study coordinator, other staff or relative thereof directly involved in the conduct of
the protocol

9. Patients that the investigator believes are unlikely to comply with the protocol, e.g.
mental condition rendering the patient unable to understand the nature, scope, and
possible consequences of participating in the clinical study, uncooperative attitude
or unlikelihood of completing the study
We found this trial at
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Phone: 773-702-6105
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-955-5000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Phone: 718-920-4531
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Phone: 800-777-8442
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-624-2620
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Chapel Hill, North Carolina 27599
Phone: 919-962-2211
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Columbus, Ohio 43210
Phone: 800-293-5066
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Phone: 214-648-3111
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Houston, Texas 77030
Phone: 713-792-2121
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2002 Holcombe Blvd
Houston, Texas 77030
(713) 791-1414
Phone: 713-791-1414
Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Phone: 323-865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Madison, Wisconsin 53792
(608) 263-2400
Phone: 608-576-0788
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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New York, New York 10016
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630 W 168th St
New York, New York
212-305-2862
Phone: 212-305-5371
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oklahoma City, Oklahoma 73104
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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