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NCT05276557 · ClinicalTrials.gov registry record · Phase 3
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
A Phase 3 study of Safety and Efficacy, sponsored by ARJ Medical.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 3
- Study locations
NCT05276557: Recruiting Phase 3 study of Safety and Efficacy, sponsored by ARJ Medical.
NCT05276557 is a Phase 3 study of Safety and Efficacy that is actively recruiting participants, run by ARJ Medical. The registered enrollment target is 40 participants, below the 125-participant average among 10 other Safety trials with a reported enrollment target (68% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05276557, a Phase 3 study of Safety and Efficacy, is actively recruiting participants, sponsored by ARJ Medical.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 3
- Study locations
Study 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. No patient management decisions should be made based on the investigational PyloPlus® UBT System. Treating physician will prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician. Total duration of study is anticipated to be approximately 6 months.
Primary Outcome
Number of participants with recorded adverse events after performing urea breath test
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Stool Antigen Test
- COMBINATION_PRODUCT PyloPlus Urea Breath Test System
Study Locations (3)
Florida
- Dolphin Medical Research - Doral
- Orlando Health, Inc. - Orlando
Texas
- Harmony United Research - El Paso
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2023-06 |
| Phase | Phase 3 |
What NCT05276557 shows while recruiting
NCT05276557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 125-participant average among 10 other Safety trials with a reported enrollment target (68% lower).
The record links to 3 conditions, with Safety appearing as the primary indexed condition, and to 2 interventions - of which Stool Antigen Test is the first listed.
NCT05276557 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT05276557 about?
NCT05276557 is a clinical study titled "PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study". 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 e...
What is the current status of trial NCT05276557?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2022-11-17. Estimated completion is 2023-06.
What conditions does trial NCT05276557 study?
This clinical trial studies the following conditions: Safety, Efficacy, Helicobacter Pylori.
What interventions are being tested in trial NCT05276557?
The interventions under investigation include: Stool Antigen Test (DIAGNOSTIC_TEST), PyloPlus Urea Breath Test System (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05276557?
This trial is sponsored by ARJ Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05276557 being conducted?
This trial has 3 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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40 8th of 10 higher than 1 of 10 other Safety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Safety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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