PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
Start Date
11/17/2022
Completion Date
6/1/2023
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 Criteria
Age Range: 3 years to 17 years
Interventions
PyloPlus Urea Breath Test System
Stool Antigen Test
Conditions
Locations
Dolphin Medical Research
Doral, Florida 33172
United States
Orlando Health, Inc.
Orlando, Florida 32806
United States
Harmony United Research
El Paso, Texas 79902
United States