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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: Completed Phase 2 study, sponsored by ARJ Medical.
NCT04036838 is a Phase 2 study that has completed, run by ARJ Medical. The registered enrollment target is 415 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (212% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary study endpoint is the performance measure in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture).
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 |
What the finished NCT04036838 record still lists
NCT04036838 is an interventional study that assigns participants to a tested intervention. The registered 415 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (212% higher).
The record links to 0 conditions, and to 4 interventions - of which PyloPlus UBT System is the first listed.
NCT04036838 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04036838's enrollment target sits among peer trials
415 93rd of 2000 higher than 1,908 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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