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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 September 2016
Main ID:  NCT02149862
Date of registration: 13/05/2014
Prospective Registration: No
Primary sponsor: Rennes University Hospital
Public title: FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors FIRBladd
Scientific title: FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors
Date of first enrolment: May 2014
Target sample size: 137
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02149862
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Karim KB Bensalah, PU-PH
Address: 
Telephone:
Email:
Affiliation:  CHU Rennes
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with an indication of partial or total bladder resection

- Lithiasic patients should be operated to a urinary calculation, without catheter
"double J"

- Free inform and written consent

Exclusion Criteria:

- Patients also treated for other cancers

- Lithiasic patients with catether "double J"

- Pregnant or breast feeding women

- Protected adults,



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Bladder Cancer
Intervention(s)
Other: Urine infrared analysis
Primary Outcome(s)
infrared spectroscopy [Time Frame: the measure will be realized at the end of the studie, an expected average 18 month after the first inclusion]
Secondary Outcome(s)
TNM system (tumor-nodes-metastasis) [Time Frame: the classification of the operating room will be carried out the day of the intervention or approximately 8 weeks after the inclusion]
Secondary ID(s)
2013-A00038-37
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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