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NCT02528721 · ClinicalTrials.gov registry record · Phase 3
Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
A Phase 3 study, sponsored by Meridian Bioscience.
- Completed
- Registry status
- Phase 3
- Development phase
- 282
- Enrollment target
NCT02528721: Completed Phase 3 study, sponsored by Meridian Bioscience.
NCT02528721 is a Phase 3 study that has completed, run by Meridian Bioscience. The registered enrollment target is 282 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02528721, a Phase 3 study, has completed, sponsored by Meridian Bioscience.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 282 participants
- Enrollment target
Study Summary
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.
Primary Outcome
Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Interventions
- DEVICE Dual Mode BreathID Hp System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT02528721 record still lists
NCT02528721 is an interventional study that assigns participants to a tested intervention. The registered 282 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 (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Dual Mode BreathID Hp System is the first listed.
NCT02528721 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02528721 about?
NCT02528721 is a clinical study titled "Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection". The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy result...
What is the current status of trial NCT02528721?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 282 participants. The study started on 2015-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02528721?
The interventions under investigation include: Dual Mode BreathID Hp System (DEVICE).
Who is sponsoring clinical trial NCT02528721?
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 NCT02528721's enrollment target sits among peer trials
282 1194th of 2000 higher than 807 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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