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

NCT02187601 | Completed

• 1 other identifier: LF-BETA-EX-0614
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease (CLD); Healthy Volunteers

Keywords

CLD

Outcome Measures

Primary Outcomes (1)

• 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.

  One hour

Secondary Outcomes (1)

• Number of subjects with adverse events related to breath test substrate

  48 hours

Study Arms (2)

CLD with MPBA and BID

EXPERIMENTAL

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.

Device: MPBA System; Device: BreathID

HV with MPBA and BID

EXPERIMENTAL

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

Device: MPBA System; Device: BreathID

Interventions

MPBA System DEVICE

MPBA is the new generation Multi Purpose Breath Analyzer

Also known as: Multi Purpose Breath Analyzer, BreathID LF

CLD with MPBA and BID; HV with MPBA and BID

BreathID DEVICE

BreathID is the name of the original Exalenz breath analyzer system

CLD with MPBA and BID; HV with MPBA and BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (1)

Assaf Harofe Medical Center

Tzrifin, Israel

Location

Study Officials

• Saleh Daher, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 11, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)