Loading clinical trials...

COMPLETEDNA

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

NCT02187601•Meridian Bioscience, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Over 18 years of age
•2. Ability and willingness to sign the Informed Consent Form
•For patient group:
•3. a. Known chronic liver disease (based on medical history)
•For healthy volunteers:
•3.b. No known liver disease (based on medical history)

Exclusion Criteria

•1. Gastric bypass surgery or extensive small bowel resection
•2. Total parenteral nutrition
•3. Pregnant or breast feeding
•4. Allergy to acetaminophen and/or other related medications.
•5. Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen).
•6. Uncontrolled malabsorption or diarrhea
•7. Placement of a transjugular intrahepatic portosystemic shunt (TIPS)
•8. Subject should not have taken any of the following for at least 48 hours prior to the breath test: Acyclovir, allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
•9. Subject should not have taken amiodarone within the last 30 days prior to the breath test

Locations (1)

Assaf Harofe Medical Center

Tzrifin, Israel

Key Dates

Start Date

August 1, 2014

Primary Completion Date

March 1, 2017

Completion Date

March 1, 2017

Last Updated

December 20, 2022

Enrollment

ACTUAL participants

Conditions

Chronic Liver Disease (CLD)Healthy Volunteers

Interventions

MPBA System

DEVICE

BreathID

DEVICE

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

NCT06342713

Healthy ParticipantsHealthy Subjects+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

A Study of ENX-104 in Healthy Participants

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Single-dose,First-in-human of KLA478