Recruiting
Phase 3

PyloPlus

Sponsor:

ARJ Medical, Inc.

Code:

NCT05681689

Conditions

Helicobacter Pylori Infection

Post-Treatment

Efficacy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PyloPlus UBT System

Histology

Rapid Urease Test

Comparator Breath Test

Stool Antigen Test

Study Details

Brief 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

Study ID

NCT05681689

Start date

Dec 21, 2022

Status verified date

May, 2023

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

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

Study Design

Enrollment

77 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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).

Interventions

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

Primary outcome measure

  • Overall Percent Agreement [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Clinical Trial Manager

877-855-4100info@gulfcoastscientific.com

Locations

Dolphin Medical Research

Recruiting

Doral, Florida, United States, 33172

Contacts

Fermin Nieto, APRN, CRC

305-870-5999

Principal Investigator:

Otto Mendoza, MD

Hudson County Clinical Trials Research Center

Recruiting

Union City, New Jersey, United States, 07087

Contacts

Jose Antonio

415-240-6322

Principal Investigator:

Tanuj Bhatnager, MD

More Information

Sponsor

ARJ Medical, Inc.

Last update posted

May 6, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ARJ Medical, Inc. on 2023-05-06.