PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Overall Percent Agreement — 7 days
  The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators

Trial sites (2)