NCT05276557

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: ARJ Medical, Inc. · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Helicobacter Pylori
• Safety
• Efficacy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-17
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-03-11
• Last updated: 2023-05-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study