The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.
Study Type
OBSERVATIONAL
Enrollment
13
Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample
One (1) Location in California
Mission Hills, California, United States
One (1) Location in Great Neck, New York
Great Neck, New York, United States
One (1) Location in Ohio
Mentor, Ohio, United States
One (1) Location in Houston, Texas
Houston, Texas, United States
Helicobacter pylori Stool Collection
In vitro diagnostic (IVD) device performance
Time frame: Through Study Completion, an average of 1 year
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One (1) Location in Bologna, Italy
Bologna, Italy