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NCT00577785 Clinical Trial

Study to Obtain Full Thickness Bladder Tissue From Subjects Undergoing Cystectomy Surgery

Cystectomy Clinical Trial

Official title:
A Multi-Center Study to Obtain Full Thickness Bladder Tissue Specimen From Subjects Undergoing Cystectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00577785
Other study ID # TNG-CL005
Secondary ID
Status Completed
Phase N/A
First received December 18, 2007
Last updated December 20, 2010
Start date August 2007
Est. completion date January 2009

Study information
Verified date December 2010
Source Tengion
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The objective of this study is to obtain bladder tissue specimens from patients otherwise undergoing cystectomy for use in research and training of personnel at Tengion, Inc.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Subjects 18 to 90 years and undergoing a cystectomy surgery

- Willing and able to give signed informed consent

Exclusion Criteria:

- Known active infection

- Known colonization with MRSA or VRE

- Receipt of blood or blood products for transfusion during the previous 3 months

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• tissue procurement
No intervention. Tissue procurement study.

Locations
Country Name City State
United States University of Southern California Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Tengion

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of bladder tissue from patients underogoing radical cystectomy ongoing throughout study No
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