ARJ C13 Urea Breath Test System

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

Study Overview

• Status: Completed
• Conditions: H. Pylori Infection
• Intervention / Treatment: Combination product: PyloPlus UBT System; Diagnostic test: Histology; Diagnostic test: Rapid Urease Test; Diagnostic test: H.pylori Culture

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 Type: Interventional
• Enrollment (Actual): 415
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States, 33765
      • American Gastroenterology and Hepatology
    • Clermont, Florida, United States, 34711
      • South Lake Gastrenology
    • Largo, Florida, United States, 33777
      • Florida Center for Gastroenterology
    • Tampa, Florida, United States, 33614
      • Habana Medical Center
    • Tampa, Florida, United States, 33629
      • Whitaker, Weintraub & Grizzard
    • Trinity, Florida, United States, 34655
      • Bay Area Gastroenterology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Indication for H.pylori testing; 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.

Combination product: PyloPlus UBT System; Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.; Diagnostic test: Histology; Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist; Diagnostic test: Rapid Urease Test; Biopsy specimen obtained and placed onto Rapid Urease Test; Diagnostic test: H.pylori Culture; Biopsy specimen obtained and sent to lab for culture analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 Visits

Collaborators and Investigators

• Sponsor: ARJ Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2015
• Primary Completion (Actual): June 14, 2017
• Study Completion (Actual): June 14, 2017

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ARJ 2014-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No