PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

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.

Eligibility

Age range

3–17 years

Sex

All

Healthy volunteers

Yes

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

Locations (3)