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NCT05276557PHASE3RecruitingAccepts Healthy Volunteers

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

ARJ Medical, Inc.

Start Date

11/17/2022

Completion Date

6/1/2023

Summary

This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample. Centers 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 prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician. Total duration of study is anticipated to be approximately 6 months.

Eligibility Criteria

Age Range: 3 years to 17 years

Inclusion Criteria: * Male or female age 3-17 at the time of visit * Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form * Naive to H. pylori treatment in the past 4 weeks 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 of the quality of 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 * Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 1/3 of the sample size was achieved for this group

Interventions

COMBINATION_PRODUCT

PyloPlus Urea Breath Test System

DIAGNOSTIC_TEST

Stool Antigen Test

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Conditions

Helicobacter PyloriSafetyEfficacy

Locations

Dolphin Medical Research

Doral, Florida 33172

United States

Orlando Health, Inc.

Orlando, Florida 32806

United States

Harmony United Research

El Paso, Texas 79902

United States