An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study pc b305/04, to Assess a Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cyst
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Bladder Cancer |
| Purpose: |
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The study is intended to investigate whether the improved initial detection and resection of
bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix
(Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences
compared to standard white light cystoscopy/TURB.
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| Study Summary: |
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A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence
rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white
light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who
underwent white light cystoscopy and TURB alone.
The present study is intended to investigate whether the improved initial detection and
resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with
Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in
recurrences compared to standard white light cystoscopy/TURB.
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| Criteria: |
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Inclusion Criteria:
- Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are
eligible to be included in this study.
Exclusion Criteria:
- Patient died during clinical study PC B305/04
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| NCT ID: |
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NCT01166230 |
| Primary Contact: |
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Principal Investigator Herbert Barton Grossman, MD The University of Texas, MD Anderson Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Nashville, Tennessee 37232 United States
There is no listed contact information for this specific location.
Site Status: Enrolling by invitation |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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