ARJ C13 Urea Breath Test System

Study Overview
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Brief Summary
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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
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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 other 13C Breath Tests.

Official Title
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ARJ C13 Urea Breath Test System

Conditions
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H. Pylori Infection

Intervention / Treatment
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* Combination Product: PyloPlus UBT System
* Diagnostic Test: Histology
* Diagnostic Test: Rapid Urease Test
* Diagnostic Test: H.pylori Culture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indication for H.pylori testing<br>Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison. | Combination Product: PyloPlus UBT System<br>* Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.<br>Diagnostic Test: Histology<br>* Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist<br>Diagnostic Test: Rapid Urease Test<br>* Biopsy specimen obtained and placed onto Rapid Urease Test<br>Diagnostic Test: H.pylori Culture<br>* Biopsy specimen obtained and sent to lab for culture analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Percent Agreement | The primary study endpoint is the performance measure in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture). | 2 Visits |