Status:
COMPLETED
ARJ C13 Urea Breath Test System
Lead Sponsor:
ARJ Medical, Inc.
Conditions:
H. Pylori Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
Detailed Description
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market. Predicate devices include: Histology, Culture, RUT, and othe...
Eligibility Criteria
Inclusion
- Male or female at least 18 years of age at the time of visit
- Patients who are experiencing the effects of gastritis
- Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study
Exclusion
- Pregnant or lactating women.
- Study subjects currently taking antibiotics
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Fasting required one hour prior to testing
- Study subjects shall not consume the following items prior to the test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to stimulate the effect of ketone production that may result from some diets), Alcohol
Key Trial Info
Start Date :
July 6 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2017
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT04036838
Start Date
July 6 2015
End Date
June 14 2017
Last Update
October 23 2019
Active Locations (6)
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1
American Gastroenterology and Hepatology
Clearwater, Florida, United States, 33765
2
South Lake Gastrenology
Clermont, Florida, United States, 34711
3
Florida Center for Gastroenterology
Largo, Florida, United States, 33777
4
Habana Medical Center
Tampa, Florida, United States, 33614