PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
NCT05681689
This study is recruiting at 2 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 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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Helicobacter Pylori Infection
- Post-Treatment
- Efficacy
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- 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 · 1
- Dolphin Medical Research · Doral, FL
New Jersey · 1
- Hudson County Clinical Trials Research Center · Union City, NJ
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.