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PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
NCT05681689 · View on ClinicalTrials.gov ↗
Study 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. No patient management decisions should be made based on the investigational PyloPlus UBT System. Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.
Conditions Studied
Interventions
- COMBINATION_PRODUCT PyloPlus UBT System
- DIAGNOSTIC_TEST Histology
- DIAGNOSTIC_TEST Rapid Urease Test
- COMBINATION_PRODUCT Comparator Breath Test
- DIAGNOSTIC_TEST Stool Antigen Test
Study Locations (2)
Florida
- Dolphin Medical Research — Doral
New Jersey
- Hudson County Clinical Trials Research Center — Union City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2022-12-21 |
| Est. Completion | 2023-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05681689
The ClinicalTrials.gov registry entry for NCT05681689 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ARJ Medical, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Helicobacter Pylori Infection appearing as the primary indexed condition, and to 5 interventions — of which PyloPlus UBT System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05681689 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05681689 about?
NCT05681689 is a clinical study titled "PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study". 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-Ur...
What is the current status of trial NCT05681689?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2022-12-21. Estimated completion is 2023-06.
What conditions does trial NCT05681689 study?
This clinical trial studies the following conditions: Helicobacter Pylori Infection, Efficacy, Post-Treatment. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05681689?
The interventions under investigation include: PyloPlus UBT System (COMBINATION_PRODUCT), Histology (DIAGNOSTIC_TEST), Rapid Urease Test (DIAGNOSTIC_TEST), Comparator Breath Test (COMBINATION_PRODUCT), Stool Antigen Test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05681689?
This trial is sponsored by ARJ Medical, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05681689 being conducted?
This trial has 2 study locations across Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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