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PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

NCT05681689 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2023-05-06

No results posted yet for this 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.

Conditions

  • Helicobacter Pylori Infection
  • Post-Treatment
  • Efficacy

Interventions

COMBINATION_PRODUCT

PyloPlus UBT System

Breath will be analyzers 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 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

COMBINATION_PRODUCT

Comparator Breath Test

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

DIAGNOSTIC_TEST

Stool Antigen Test

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

Sponsors & Collaborators

  • ARJ Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-21
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05681689 on ClinicalTrials.gov