PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

Phase 3RecruitingNCT05681689

ARJ Medical, Inc.77 enrolled

Overview

This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples. Center(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System. Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Helicobacter Pylori Infection Post-Treatment Efficacy

Interventions

PyloPlus UBT SystemCOMBINATION_PRODUCT

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

HistologyDIAGNOSTIC_TEST

Biopsy specimen fixed with 10% buffered formalin 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

Comparator Breath TestCOMBINATION_PRODUCT

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

Stool Antigen TestDIAGNOSTIC_TEST

An antigen test performed via a laboratory to test patient's stool for H. pylori

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or Female at least 18 years of age * Patients who have been diagnosed with H. pylori and have been treated within the past 6 months * Naive to H. pylori treatment in the past 4 weeks (including PPIs) Exclusion Criteria: * Pregnant and/or lactating women. * 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. * Participation in other interventional trials. * Allergy to test substrates. * Antibiotics taken within 4 weeks of the testing. * Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food

Locations (2)

Dolphin Medical Research

Doral, Florida, United States

RECRUITING

Hudson County Clinical Trials Research Center

Union City, New Jersey, United States