NCT05681689

PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: ARJ Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
DIAGNOSTIC_TEST	Rapid Urease Test	Biopsy specimen obtained and placed onto Rapid Urease Test
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

Timeline

• Start date: 2022-12-21
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2023-01-12
• Last updated: 2023-05-06

Locations

2 sites across 1 country: United States

Regulatory

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