NCT05276557View on ClinicalTrials.gov

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

PHASE3RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 17, 2022

Primary Completion Date

June 30, 2023

Study Completion Date

June 30, 2023

Conditions
Helicobacter PyloriSafetyEfficacy
Interventions
COMBINATION_PRODUCT

PyloPlus Urea Breath Test System

System containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.

DIAGNOSTIC_TEST

Stool Antigen Test

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

Trial Locations (3)

32806

RECRUITING

Orlando Health, Inc., Orlando

33172

RECRUITING

Dolphin Medical Research, Doral

79902

RECRUITING

Harmony United Research, El Paso

Sponsors

Lead Sponsor

ARJ Medical, Inc.
All Listed Sponsors
lead

ARJ Medical, Inc.

INDUSTRY