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NCT04036838 · ClinicalTrials.gov registry record · Phase 2
ARJ C13 Urea Breath Test System
A Phase 2 study, sponsored by ARJ Medical.
- Completed
- Registry status
- Phase 2
- Development phase
- 415
- Enrollment target
NCT04036838 is a Phase 2 study that has completed, run by ARJ Medical. The registered enrollment target is 415 participants.
The verdict
NCT04036838, a Phase 2 study, has completed, sponsored by ARJ Medical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 415 participants
- Enrollment target
Study Summary
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
Interventions
- COMBINATION_PRODUCT PyloPlus UBT System
- DIAGNOSTIC_TEST Histology
- DIAGNOSTIC_TEST Rapid Urease Test
- DIAGNOSTIC_TEST H.pylori Culture
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 415 participants |
| Start Date | 2015-07-06 |
| Est. Completion | 2017-06-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04036838
The ClinicalTrials.gov registry entry for NCT04036838 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 415 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ARJ Medical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which PyloPlus UBT System is the first listed.
NCT04036838 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04036838 about?
NCT04036838 is a clinical study titled "ARJ C13 Urea Breath Test System". An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
What is the current status of trial NCT04036838?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 415 participants. The study started on 2015-07-06. Estimated completion is 2017-06-14.
What interventions are being tested in trial NCT04036838?
The interventions under investigation include: PyloPlus UBT System (COMBINATION_PRODUCT), Histology (DIAGNOSTIC_TEST), Rapid Urease Test (DIAGNOSTIC_TEST), H.pylori Culture (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04036838?
This trial is sponsored by ARJ Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
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