The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.
This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).
Study Type
OBSERVATIONAL
Enrollment
98
Del Sol Research Management, Inc.
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Medley Research Associates
Medley, Florida, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Non-invasive collection procedure
This study is designed to collect specimens to supplement repository specimens for product validation purposes. The endoscopy results and specimens will be used in a future clinical trial of a non-invasive in vitro diagnostic assay for the detection of H. pylori antigen. institutional review board approval is sought in order to be able to use human specimens for validation of in vitro diagnostics.
Time frame: 1 year
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