ARJ C13 Urea Breath Test System

Phase 2

Completed

• Conditions: H. Pylori Infection

• Registration Number: NCT04036838
• Lead Sponsor: ARJ Medical, Inc.

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.

Study Timeline

• Study Start: 2015-07-06
• Primary Completion: 2017-06-14
• Study Completion: 2017-06-14
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Results First Submitted: 2019-07-29
• Study First Posted: 2019-07-30
• Results First Submitted QC: 2019-09-10
• Status Verified: 2019-10
• Results First Posted: 2019-10-02
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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).

Trial Locations

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

Whitaker, Weintraub & Grizzard; 🇺🇸 Tampa, Florida, United States

Bay Area Gastroenterology Associates; 🇺🇸 Trinity, Florida, United States