BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.

Inclusion Criteria:

• Age >18 with chronic liver disease

Exclusion Criteria:

• Patients that are taking hepatotoxin drug.
• Patient with severe congestive heart failure
• Patient with severe pulmonary hypertension
• Patient with uncontrolled diabetes mellitus
• Patient with previous surgical bypass surgery for morbid obesity
• Patient with extensive small bowel resection
• Patient currently receiving total parenteral nutrition
• Patient is a recipients of any organ transplant
• Patients that received any anti-viral treatment within the past year
• Women who are pregnant
• Patient allergic to acetaminophen (such as Tylenol or any other related medications)
• Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
• Patients unable to sign informed consent
• Patients that based on the opinion of the investigator should not be enrolled into this study
• Patients that are participating in other clinical trials evaluating experimental treatments or procedures