Blue Light Cystoscopy With Cysview® Registry
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Photocure
- Study ID
- NCT02660645
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Hexaminolevulinate hydrochloride (HCL) — DRUGInstillation in bladder
- Karl Storz D-Light C Photodynamic Diagnostic (PDD) system — DEVICECystoscopy procedure
Study Details
Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.
Key Dates
- Start date
- Apr 30, 2014
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 4,400 participants (estimated)
Arms
- Arm: Blue Light Cystoscopy with Cysview®Bladder cancer patients who have undergone Blue light cystoscopy with Hexaminolevulinate hydrochloride (Cysview®) 100mg in 50 milliliters (mL) reconstituted solution instilled intravesically into bladder prior to cystoscopy in operating room (OR). Retention time: 1-3 hours. The Karl Storz D-Light C Photodynamic Diagnostic (PDD) system is used for the cystoscopy procedure at the OR examination.
Primary Outcome Measure
Rate of detection of bladder malignancies [ Time Frame: 5 years ]
Central Contacts
- Chad McKee, PhD(919) 780-0417
Locations (23)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Charles Peyton, MD Charles Peyton, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Phoenix | Arizona | 85054 | Mark Tyson, MD, MPH Mark Tyson, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| University of California Los Angeles | Los Angeles | California | 90095 | Karim Chamie, MD 310-794-7700 Karim Chamie, MD (PRINCIPAL_INVESTIGATOR) |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Sia Daneshmand, MD (PRINCIPAL_INVESTIGATOR) Anne Schuckman, MD (SUB_INVESTIGATOR) Mihir Desai, MD (SUB_INVESTIGATOR) Hooman Djaladat, MD (SUB_INVESTIGATOR) Gerhard Fuchs, MD (SUB_INVESTIGATOR) Virinder Bhardwaj, MD (SUB_INVESTIGATOR) |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | Dorothy Trivedi Joseph Liao, MD (PRINCIPAL_INVESTIGATOR) James Crotty, MD (SUB_INVESTIGATOR) John Leppert, MD (SUB_INVESTIGATOR) John Lavelle, MD (SUB_INVESTIGATOR) |
| University of California, San Francisco | San Francisco | California | 94143 | Sima Porten, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | Armine Smith, MD 202-660-5561 Armine Smith, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University School of Medicine | Atlanta | Georgia | 30097 | Vikram Narayan, MD (404) 778-4898 Vikram Narayan, MD (PRINCIPAL_INVESTIGATOR) Shreyas Joshi, MD (SUB_INVESTIGATOR) |
| Northwestern University | Chicago | Illinois | 60611 | Clay Arnett Joshua Meeks, MD (PRINCIPAL_INVESTIGATOR) |
| Northshore University Health System | Evanston | Illinois | 60201 | Adam Vanderloo Kristian Novakovic, MD (PRINCIPAL_INVESTIGATOR) |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Lehman G Jennifer, RN, CCRP Hristos Z Kaimakliotis, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | John Taylor, MD, MS (PRINCIPAL_INVESTIGATOR) Jeffrey Holzbeierlein, MD, FACS (SUB_INVESTIGATOR) |
| Johns Hopkins Medicine | Baltimore | Maryland | 21224 | Morgan De Carli Max Kates, MD (PRINCIPAL_INVESTIGATOR) |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Hamed Ahmadi, MD (PRINCIPAL_INVESTIGATOR) Subodh Regmi, MD (SUB_INVESTIGATOR) |
| NYU Langone's Perlmutter Cancer Center | New York | New York | 10016 | Gary Steinberg, MD 646-825-6300 Gary Steinberg, MD (PRINCIPAL_INVESTIGATOR) |
| Stony Brook Urology | Stony Brook | New York | 11794 | - |
| Ohio State University | Columbus | Ohio | 43210 | Rachel Link, CCRP Kamal S Pohar, MD (PRINCIPAL_INVESTIGATOR) |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | Kamal Pohar, MD Kamal Pohar, MD (PRINCIPAL_INVESTIGATOR) Megan Merrill, DO (SUB_INVESTIGATOR) Ahmad Shabsigh, MD (SUB_INVESTIGATOR) David Sharp, MD (SUB_INVESTIGATOR) |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | T. Brian Willard, MD (PRINCIPAL_INVESTIGATOR) David Lamb, MD (SUB_INVESTIGATOR) Scott Sweazy, MD (SUB_INVESTIGATOR) Keith Birghtbill, MD (SUB_INVESTIGATOR) Michael Stotzer, MD (SUB_INVESTIGATOR) |
| UT Southwestern | Dallas | Texas | 75390 | Yair Lotan, MD 214-645-8787 Yair Lotan, MD (PRINCIPAL_INVESTIGATOR) Aditya Bagrodia, MD (SUB_INVESTIGATOR) |
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | Jennifer Taylor, MD, MPH (PRINCIPAL_INVESTIGATOR) Jeffrey Jones, MD (SUB_INVESTIGATOR) Sidney Worsham, MD (SUB_INVESTIGATOR) |
| University of Washington Medicine | Seattle | Washington | 98195 | John Gore, MD (206) 598-4294 John Gore, MD (PRINCIPAL_INVESTIGATOR) |
| Charleston Area Medical Center | Charleston | West Virginia | 25301 | - |
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