<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02187601</url>
  </required_header>
  <id_info>
    <org_study_id>LF-BETA-EX-0614</org_study_id>
    <nct_id>NCT02187601</nct_id>
  </id_info>
  <brief_title>Equivalence of New Breath AnalyzerCompared to Currently BreathID System in Assessment of Liver Function</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meridian Bioscience, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meridian Bioscience, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to confirm that the new generation state of the art breath analyzer&#xD;
      gives equivalent results to the previous model of the Exalenz breath analyzer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy and chronic liver disease subjects of all grades will be tested to see that the two&#xD;
      devices give equivalent results in both devices. Subjects will be connected to both devices&#xD;
      at the same time and will be tested for one hour.&#xD;
&#xD;
      The breath test includes automatic baseline breath collection, 13C-Methacetin ingestion in&#xD;
      solution and breath collection post ingestion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DOB Peak</measure>
    <time_frame>One hour</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events related to breath test substrate</measure>
    <time_frame>48 hours</time_frame>
    <description>Adverse events within 48 hours of the breath test will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Liver Disease (CLD)</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>CLD with MPBA and BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HV with MPBA and BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MPBA System</intervention_name>
    <description>MPBA is the new generation Multi Purpose Breath Analyzer</description>
    <arm_group_label>CLD with MPBA and BID</arm_group_label>
    <arm_group_label>HV with MPBA and BID</arm_group_label>
    <other_name>Multi Purpose Breath Analyzer</other_name>
    <other_name>BreathID LF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BreathID</intervention_name>
    <description>BreathID is the name of the original Exalenz breath analyzer system</description>
    <arm_group_label>CLD with MPBA and BID</arm_group_label>
    <arm_group_label>HV with MPBA and BID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Over 18 years of age&#xD;
&#xD;
          2. Ability and willingness to sign the Informed Consent Form&#xD;
&#xD;
             For patient group:&#xD;
&#xD;
          3. a. Known chronic liver disease (based on medical history)&#xD;
&#xD;
        For healthy volunteers:&#xD;
&#xD;
        3.b. No known liver disease (based on medical history)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastric bypass surgery or extensive small bowel resection&#xD;
&#xD;
          2. Total parenteral nutrition&#xD;
&#xD;
          3. Pregnant or breast feeding&#xD;
&#xD;
          4. Allergy to acetaminophen and/or other related medications.&#xD;
&#xD;
          5. Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or&#xD;
             drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen).&#xD;
&#xD;
          6. Uncontrolled malabsorption or diarrhea&#xD;
&#xD;
          7. Placement of a transjugular intrahepatic portosystemic shunt (TIPS)&#xD;
&#xD;
          8. Subject should not have taken any of the following for at least 48 hours prior to the&#xD;
             breath test: Acyclovir, allopurinol, carbamazepine, cimetidine, ciprofloxacin,&#xD;
             daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine,&#xD;
             methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin,&#xD;
             propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or&#xD;
             oral contraceptives or any medication that might interfere with Methacetin metabolism&#xD;
             or might affect CYP 1A2&#xD;
&#xD;
          9. Subject should not have taken amiodarone within the last 30 days prior to the breath&#xD;
             test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saleh Daher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assaf Harofe Medical Center</name>
      <address>
        <city>Tzrifin</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CLD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02187601
org study id: LF-BETA-EX-0614
nct id: NCT02187601
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: DOB Peak
time frame: One hour
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.
measure: Number of subjects with adverse events related to breath test substrate
time frame: 48 hours
description: Adverse events within 48 hours of the breath test will be recorded
arm group label: CLD with MPBA and BID
arm group type: Experimental
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.
arm group label: HV with MPBA and BID
arm group type: Experimental
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: MPBA System
description: MPBA is the new generation Multi Purpose Breath Analyzer
arm group label: CLD with MPBA and BID
arm group label: HV with MPBA and BID
other name: Multi Purpose Breath Analyzer
other name: BreathID LF
intervention type: Device
intervention name: BreathID
description: BreathID is the name of the original Exalenz breath analyzer system
arm group label: CLD with MPBA and BID
arm group label: HV with MPBA and BID
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Saleh Daher, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Liver Diseases
sharing ipd: No