NCT02187601

Equivalence of New Breath AnalyzerCompared to Currently BreathID System in Assessment of Liver Function

Beta Study to Evaluate Functionality and Equivalence of MPBA (Multi Purpose Breath Analyzer-new Generation Exalenz Breath Analyzer) Compared to Currently Approved BreathID System in Assessment of Liver Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to confirm that the new generation state of the art breath analyzer gives equivalent results to the previous model of the Exalenz breath analyzer.

Detailed description

Healthy and chronic liver disease subjects of all grades will be tested to see that the two devices give equivalent results in both devices. Subjects will be connected to both devices at the same time and will be tested for one hour. The breath test includes automatic baseline breath collection, 13C-Methacetin ingestion in solution and breath collection post ingestion.

Conditions

• Chronic Liver Disease (CLD)
• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	MPBA System	MPBA is the new generation Multi Purpose Breath Analyzer
DEVICE	BreathID	BreathID is the name of the original Exalenz breath analyzer system

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2014-07-11
• Last updated: 2022-12-20

Locations

1 site across 1 country: Israel