ARJ C13 Urea Breath Test System

ARJ Medical

Status and phase: Completed; Phase 2

Conditions: H. Pylori Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04036838

ARJ 2014-01

Details and patient eligibility

About

An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.

Full 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.

Enrollment: 415 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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415 participants in 1 patient group

Indication for H.pylori testing

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Rapid Urease Test

Diagnostic Test: H.pylori Culture

Diagnostic Test: Histology

Combination Product: PyloPlus UBT System