PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
NCT05276557
This study is recruiting at 3 US sites in 2 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Helicobacter Pylori
- Safety
- Efficacy
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- ARJ Medical, Inc.
- Last updated on ClinicalTrials.gov
- May 6, 2023
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Florida · 2
- Dolphin Medical Research · Doral, FL
- Orlando Health, Inc. · Orlando, FL
Texas · 1
- Harmony United Research · El Paso, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.