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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 is a Phase 3 study that has completed, run by Meridian Bioscience. The registered enrollment target is 282 participants.

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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.

Interventions

  • DEVICE Dual Mode BreathID Hp System

Trial Details

FieldValue
Enrollment Target 282 participants
Start Date 2015-10
Est. Completion 2016-07
Phase Phase 3

Sponsor

Meridian Bioscience

19 total trials

What the Registry Record Tells You About NCT02528721

The ClinicalTrials.gov registry entry for NCT02528721 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Meridian Bioscience, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Dual Mode BreathID Hp System is the first listed.

NCT02528721 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.