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Clinical Trials in the USA / NCT05681689
Recruiting Phase 3

PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

NCT05681689 · tracked via the Priya Life Science USA tracker
Sponsor
ARJ Medical, Inc
Phase
Phase 3
Started
2022-12-21
Last updated
2023-05-06

Condition(s) studied

Helicobacter Pylori InfectionPost-TreatmentEfficacy

Investigational drug(s) / intervention(s)

PyloPlus UBT SystemHistologyRapid Urease TestComparator Breath TestStool Antigen Test

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

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

Rapid Urease Test: Biopsy specimen obtained and placed onto Rapid Urease Test

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

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Overall Percent Agreement — 7 days
    The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators

Trial sites (2)

FacilityCityRegionStatus
Dolphin Medical Research Doral Florida Recruiting
Hudson County Clinical Trials Research Center Union City New Jersey Recruiting

More ARJ Medical, Inc. trials in the USA

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study Recruiting

Other trials for the same condition

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study Recruiting
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05681689 on ClinicalTrials.gov ↗ ← All trials in the USA