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

NCT ID: NCT02187601

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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

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Chronic Liver Disease (CLD) Healthy Volunteers

Keywords

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CLD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CLD with MPBA and BID

Chronic Liver Disease (CLD) patients of all degrees will be offered to be tested on the MPBA (multi purpose breath analyzer) and BID (BreathID) on a walk- in basis with , proving they meet inclusion/exclusion criteria.

Group Type EXPERIMENTAL

MPBA System

Intervention Type DEVICE

MPBA is the new generation Multi Purpose Breath Analyzer

BreathID

Intervention Type DEVICE

BreathID is the name of the original Exalenz breath analyzer system

HV with MPBA and BID

Healthy volunteers (HV) with no known liver disease will undergo the breath test with the MPBA and the BID before and after substrate ingestion.

Group Type EXPERIMENTAL

MPBA System

Intervention Type DEVICE

MPBA is the new generation Multi Purpose Breath Analyzer

BreathID

Intervention Type DEVICE

BreathID is the name of the original Exalenz breath analyzer system

Interventions

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MPBA System

MPBA is the new generation Multi Purpose Breath Analyzer

Intervention Type DEVICE

BreathID

BreathID is the name of the original Exalenz breath analyzer system

Intervention Type DEVICE

Other Intervention Names

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Multi Purpose Breath Analyzer BreathID LF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meridian Bioscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saleh Daher, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Assaf Harofe Medical Center

Tzrifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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LF-BETA-EX-0614

Identifier Type: -

Identifier Source: org_study_id