ARJ C13 Urea Breath Test System

Phase 2

Completed

Interventions: Combination Product: PyloPlus UBT System
Diagnostic Test: Histology
Diagnostic Test: Rapid Urease Test
Diagnostic Test: H.pylori Culture

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 other 13C Breath Tests.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Indication for H.pylori testing	H.pylori Culture	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.
Indication for H.pylori testing	Rapid Urease Test	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.
Indication for H.pylori testing	PyloPlus UBT System	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.
Indication for H.pylori testing	Histology	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.

Primary Outcome Measures

Name	Time	Method
Overall Percent Agreement	2 Visits	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).

Secondary Outcome Measures

Name	Time	Method

Locations (6): American Gastroenterology and Hepatology
🇺🇸
Clearwater, Florida, United States
Florida Center for Gastroenterology
🇺🇸
Largo, Florida, United States
Habana Medical Center
🇺🇸
Tampa, Florida, United States
Whitaker, Weintraub & Grizzard
🇺🇸
Tampa, Florida, United States
South Lake Gastrenology
🇺🇸
Clermont, Florida, United States
Bay Area Gastroenterology Associates
🇺🇸
Trinity, Florida, United States