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Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection

NCT01650831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2022-12-20

Study results available
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Summary

The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.

Conditions

  • Suspicion of Being Infected With H.Pylori

Interventions

DEVICE

Modified BreathID

A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Jenny Liu, MD · Unimed Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-11-30
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01650831 on ClinicalTrials.gov