Development of a Breath Test for Monitoring Patients With Liver Disease

Completed · Phase 3

Conditions studied: Fatty Liver, Cirrhosis

In brief

The purpose of this study is to determine the safety and efficacy of the Oridion Breath ID machine in monitoring liver metabolic functions.

Key facts

Study ID

NCT00244569

Run by

Virginia Commonwealth University

People needed

120

Starts

2005-09-01

Expected to finish

2007-04-01

Last updated by the study team

2017-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult men and women (age 18+)
• Liver histology consistent with NAFLD/NASH performed within the past 24 months
• Patients with cirrhosis must have ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) examination of liver performed within the previous 6 months demonstrating no evidence for hepatocellular carcinoma

You may not qualify if…

• Any liver disease beyond NAFLD/NASH
• Severe congestive heart failure
• Severe pulmonary hypertension
• Chronic renal insufficiency defined by a serum creatinine above normal
• Uncontrolled diabetes mellitus
• Any autoimmune disorder which is currently being treated with immune suppressive medication
• Proven or suspected hepatocellular carcinoma
• Previous surgical bypass surgery for morbid obesity
• Extensive small bowel resection
• Patients currently receiving total parenteral nutrition
• Recipients of any organ transplant
• Women who are pregnant
• Patients who, in the opinion of the investigator, should not be enrolled in this study

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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