Trials / Completed
CompletedNCT02970110
Specimen Collection Study for H. Pylori Testing
Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 98 (actual)
- Sponsor
- Biomerica · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
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 description
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).
Conditions
Timeline
- Start date
- 2017-02-27
- Primary completion
- 2020-03-01
- Completion
- 2020-03-01
- First posted
- 2016-11-21
- Last updated
- 2022-03-18
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02970110. Inclusion in this directory is not an endorsement.