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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection; Efficacy; Post-Treatment
• Intervention / Treatment: Diagnostic test: Rapid Urease Test; Combination product: PyloPlus UBT System; Diagnostic test: Histology; Combination product: Comparator Breath Test; Diagnostic test: Stool Antigen Test

• Study Type: Interventional
• Enrollment (Anticipated): 77
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trial Manager; Phone Number: 877-855-4100; Email: info@gulfcoastscientific.com

Study Locations

• United States
  • Florida
    • Doral, Florida, United States, 33172
      • Recruiting
      • Dolphin Medical Research
      • Contact: Fermin Nieto, APRN, CRC; Phone Number: 305-870-5999
      • Principal Investigator: Otto Mendoza, MD
  • New Jersey
    • Union City, New Jersey, United States, 07087
      • Recruiting
      • Hudson County Clinical Trials Research Center
      • Contact: Jose Antonio; Phone Number: 415-240-6322
      • Principal Investigator: Tanuj Bhatnager, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Indication for H. pylori testing; Patients who have been treated for H. pylori and need to undergo eradication confirmation testing. Patients will be enrolled for this study if all acceptance criteria are met. Patients will undergo 13C Urea Breath Test in addition to non-invasive diagnostic comparators (H. pylori Stool Testing and Comparator Breath Test) OR invasive diagnostic comparator (Endoscopy for Rapid Urease Testing and Histology).

Diagnostic test: Rapid Urease Test; Biopsy specimen obtained and placed onto Rapid Urease Test; 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Percent Agreement	The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators	7 days

Collaborators and Investigators

• Sponsor: ARJ Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: December 28, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ARJ-2022-UBTPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes