Status:
COMPLETED
Equivalence of New Breath AnalyzerCompared to Currently BreathID System in Assessment of Liver Function
Lead Sponsor:
Meridian Bioscience, Inc.
Conditions:
Chronic Liver Disease (CLD)
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02187601
Start Date
August 1 2014
End Date
March 1 2017
Last Update
December 20 2022
Active Locations (1)
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1
Assaf Harofe Medical Center
Tzrifin, Israel