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PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
Sponsor: ARJ Medical, Inc.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
77
Start Date
2022-12-21
Completion Date
2023-06
Last Updated
2023-05-06
Healthy Volunteers
Yes
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
Locations (2)
Dolphin Medical Research
Doral, Florida, United States
Hudson County Clinical Trials Research Center
Union City, New Jersey, United States