Clinical Trial: Specimen Collection Study for H. Pylori Testing
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia
Brief Summary: 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.
Detailed Summary: 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).
Sponsor: Biomerica
Current Primary Outcome: Non-invasive collection procedure [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Biomerica
Dates:
Date Received: November 17, 2016
Date Started: January 2017
Date Completion: December 2017
Last Updated: November 17, 2016
Last Verified: November 2016