ARJ C13 Urea Breath Test System

ARJ Medical, Inc.415 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

415

Conditions

H. Pylori Infection

Interventions

PyloPlus UBT SystemCOMBINATION_PRODUCT

Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.

HistologyDIAGNOSTIC_TEST

Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist

Rapid Urease TestDIAGNOSTIC_TEST

Biopsy specimen obtained and placed onto Rapid Urease Test

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

American Gastroenterology and Hepatology

Clearwater, Florida, United States

South Lake Gastrenology

Clermont, Florida, United States

Florida Center for Gastroenterology

Largo, Florida, United States

Habana Medical Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: 2 Visits

Data from ClinicalTrials.gov

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