Back to results

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

Primary Purpose

Chronic Liver Disease (CLD), Healthy Volunteers

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

MPBA System

BreathID

About this trial

This is an interventional diagnostic trial for Chronic Liver Disease (CLD) focused on measuring CLD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Over 18 years of age
Ability and willingness to sign the Informed Consent Form
For patient group:
a. Known chronic liver disease (based on medical history)

For healthy volunteers:

3.b. No known liver disease (based on medical history)

Exclusion Criteria:

Gastric bypass surgery or extensive small bowel resection
Total parenteral nutrition
Pregnant or breast feeding
Allergy to acetaminophen and/or other related medications.
Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen).
Uncontrolled malabsorption or diarrhea
Placement of a transjugular intrahepatic portosystemic shunt (TIPS)
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
Subject should not have taken amiodarone within the last 30 days prior to the breath test

Sites / Locations

Assaf Harofe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CLD with MPBA and BID

HV with MPBA and BID

Arm Description

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.

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

Outcomes

Primary Outcome Measures

DOB Peak

The DOB (Delta over Baseline) is measured before and after ingestion of challenging test substrate: 13C- Methacetin. The peak of the DOB is indicative of liver health.

Secondary Outcome Measures

Number of subjects with adverse events related to breath test substrate

Adverse events within 48 hours of the breath test will be recorded

Full Information

NCT ID

NCT02187601

First Posted

July 7, 2014

Last Updated

December 19, 2022

Sponsor

Meridian Bioscience, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02187601

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meridian Bioscience, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Liver Disease (CLD), Healthy Volunteers

Keywords

CLD

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CLD with MPBA and BID

Arm Type

Experimental

Arm Description

Arm Title

HV with MPBA and BID

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MPBA System

Other Intervention Name(s)

Multi Purpose Breath Analyzer, BreathID LF

Intervention Description

MPBA is the new generation Multi Purpose Breath Analyzer

Intervention Type

Device

Intervention Name(s)

BreathID

Intervention Description

BreathID is the name of the original Exalenz breath analyzer system

Primary Outcome Measure Information:

Title

DOB Peak

Description

The DOB (Delta over Baseline) is measured before and after ingestion of challenging test substrate: 13C- Methacetin. The peak of the DOB is indicative of liver health.

Time Frame

One hour

Secondary Outcome Measure Information:

Title

Number of subjects with adverse events related to breath test substrate

Description

Adverse events within 48 hours of the breath test will be recorded

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over 18 years of age Ability and willingness to sign the Informed Consent Form For patient group: a. Known chronic liver disease (based on medical history) For healthy volunteers: 3.b. No known liver disease (based on medical history) Exclusion Criteria: Gastric bypass surgery or extensive small bowel resection Total parenteral nutrition Pregnant or breast feeding Allergy to acetaminophen and/or other related medications. Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen). Uncontrolled malabsorption or diarrhea Placement of a transjugular intrahepatic portosystemic shunt (TIPS) 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 Subject should not have taken amiodarone within the last 30 days prior to the breath test

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saleh Daher, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assaf Harofe Medical Center

City

Tzrifin

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs