NCT02187601CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Meridian Bioscience, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- DOB Peak
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
DOB Peak
Time Frame: One hour
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 Outcomes
- Number of subjects with adverse events related to breath test substrate(48 hours)
Investigators
Study Sites (1)
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