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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Photocure
Study ID
NCT02560584
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 1, 2015
Status verified
May 2018
Primary completion
Apr 5, 2017
Completion
Apr 5, 2017

Study Design

Enrollment
304 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cysview arm
    In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure) All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours. Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System

Primary Outcome Measure

Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy [ Time Frame: At time of cystoscopy procedure ]

Locations (17)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of Chicago Medical CenterChicagoIllinois60637-
University of IowaIowa CityIowa52242-
Johns Hopkins UniversityBaltimoreMaryland21205-
University of MinnesotaMinneapolisMinnesota55455-
Columbia University Medical CenterNew YorkNew York10032-
NYU Langone Urology AssociatesNew YorkNew York10016-
Montefiore Medical CenterThe BronxNew York10461-
University of North Carolina, Department of UrologyChapel HillNorth Carolina27599-
Ohio State University The James Cancer HospitalColumbusOhio43210-
University of Oklahoma-Stephenson Cancer CenterOklahoma CityOklahoma73104-
Thomas Jefferson UniversityPhiladelphiaPennsylvania10197-
Vanderbilt University Medical CenterNashvilleTennessee37232-
UT Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
Michael E. DeBakey VA Medical CenterHoustonTexas77030-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Los Angeles, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of Chicago Medical Center· Chicago, ILUniversity of Iowa· Iowa City, IAJohns Hopkins University· Baltimore, MDUniversity of Minnesota· Minneapolis, MNColumbia University Medical Center· New York, NY

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