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NCT02010112 · ClinicalTrials.gov registry record · Phase 3
Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
A Phase 3 study, sponsored by Meridian Bioscience.
- Completed
- Registry status
- Phase 3
- Development phase
- 193
- Enrollment target
NCT02010112: Completed Phase 3 study, sponsored by Meridian Bioscience.
NCT02010112 is a Phase 3 study that has completed, run by Meridian Bioscience. The registered enrollment target is 193 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02010112, a Phase 3 study, has completed, sponsored by Meridian Bioscience.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 193 participants
- Enrollment target
Study Summary
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
Primary Outcome
The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test.
Interventions
- OTHER Breath Test Collection bags
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT02010112 record still lists
NCT02010112 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Breath Test Collection bags is the first listed.
NCT02010112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02010112 about?
NCT02010112 is a clinical study titled "Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori". A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
What is the current status of trial NCT02010112?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 193 participants. The study started on 2014-01. Estimated completion is 2015-02.
What interventions are being tested in trial NCT02010112?
The interventions under investigation include: Breath Test Collection bags (OTHER).
Who is sponsoring clinical trial NCT02010112?
This trial is sponsored by Meridian Bioscience, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02010112's enrollment target sits among peer trials
193 1397th of 2000 higher than 603 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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