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NCT05681689 · ClinicalTrials.gov registry record · Phase 3
PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
A Phase 3 study of Helicobacter Pylori Infection and Efficacy, sponsored by ARJ Medical.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
- 2
- Study locations
NCT05681689: Recruiting Phase 3 study of Helicobacter Pylori Infection and Efficacy, sponsored by ARJ Medical.
NCT05681689 is a Phase 3 study of Helicobacter Pylori Infection and Efficacy that is actively recruiting participants, run by ARJ Medical. The registered enrollment target is 77 participants, below the 347-participant average among 4 other Helicobacter Pylori Infection trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05681689, a Phase 3 study of Helicobacter Pylori Infection and Efficacy, is actively recruiting participants, sponsored by ARJ Medical.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators
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 |
What NCT05681689 shows while recruiting
NCT05681689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 347-participant average among 4 other Helicobacter Pylori Infection trials with a reported enrollment target (78% lower).
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.
NCT05681689 reports a single indexed study location in Florida, New Jersey.
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.
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).
Who is sponsoring clinical trial NCT05681689?
This trial is sponsored by ARJ Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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