ARJ C13 Urea Breath Test System

Completed · Phase 2

Conditions studied: H. Pylori Infection

In brief

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

Key facts

Study ID

NCT04036838

Run by

ARJ Medical, Inc.

People needed

415

Starts

2015-07-06

Expected to finish

2017-06-14

Last updated by the study team

2019-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Whitaker, Weintraub & Grizzard — Tampa, Florida, United States
• Bay Area Gastroenterology Associates — Trinity, Florida, United States

Full record on ClinicalTrials.gov

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