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Completed

NCT Number: NCT04036838

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.

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Key information

Conditions

H. Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

American Gastroenterology and Hepatology, Clearwater, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PyloPlus UBT System

Combination Product

Breath will be analyzed 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 were 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

H.pylori Culture

Diagnostic Test

Biopsy specimen obtained and sent to lab for culture analysis

Primary outcomes

  1. Overall Percent Agreement

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

ARJ Medical, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 30, 2019
Registry last updated
Oct 23, 2019

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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