Phase 2
Completed N=415
ARJ C13 Urea Breath Test System
H. Pylori Infection
Source: ClinicalTrials.gov NCT04036838 ↗
Enrolled (actual)
415
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Overall Percent Agreement — 98.40; 99.20 percentage of pos. agreement
Summary
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Percent Agreement |
98.40; 99.20 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04036838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.