CompletedNot Applicable

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

Israel20 participantsStarted 2014-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

What they're measuring

DOB Peak

Timeframe: One hour

Trial details

NCT IDNCT02187601

SponsorMeridian Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03

View on ClinicalTrials.gov More Chronic Liver Disease (CLD) trials