Study to Confirm Effectiveness of PyloPlus Urea Breath Test for Checking H. pylori Infection After Treatment

What this Trial Is About

Researchers are evaluating the PyloPlus Urea Breath Test System to confirm the effectiveness of treatment for Helicobacter pylori infection. This multi-center, non-randomized, open-label study includes patients who have been treated for H. pylori within the past six months and aims to compare the PyloPlus system results with other diagnostic methods. The study is sponsored by ARJ Medical, Inc. and is conducted in a Phase 3 setting. Participants will undergo testing with the PyloPlus UBT System, which measures carbon-13 content in breath after ingesting a special urea compound. In addition, patients may have stool antigen testing and a comparator breath test or undergo an endoscopy for rapid urease testing and histology as diagnostic comparisons. The PyloPlus test results are kept blinded from treating physicians, who will manage patient care independently. During the study, participants will provide breath samples analyzed by the PyloPlus UBT Analyzer and may submit stool samples or undergo endoscopy with biopsy. The main outcome measured is the overall percent agreement of the PyloPlus test results compared to standard diagnostic tests within seven days. The study includes safety monitoring and does not influence clinical management decisions based on the investigational test results.

PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study