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NCT Number: NCT05681689

PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

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.

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Key information

Conditions

Helicobacter Pylori Infection Efficacy Post-Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dolphin Medical Research, Doral, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PyloPlus UBT System

Combination Product

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

Histology

Diagnostic Test

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

rapid urease test

Diagnostic Test

Biopsy specimen obtained and placed onto Rapid Urease Test

Comparator Breath Test

Combination Product

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

Stool Antigen Test

Diagnostic Test

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

Primary outcomes

  1. Overall Percent Agreement

    Time frame: 7 days

    The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Manager

CONTACT

[email protected]

877-855-4100

Sponsors and collaborators

Lead sponsor

ARJ Medical, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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