Status:
COMPLETED
Development of a Breath Test for Monitoring Patients With Liver Disease
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Oridion
Conditions:
Fatty Liver
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and efficacy of the Oridion Breath ID machine in monitoring liver metabolic functions.
Detailed Description
Percutaneous liver biopsy has been utilized for decades to assess the severity of chronic liver disease, regardless of etiology. During this procedure a core sample of liver is obtained and examined h...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00244569
Start Date
September 1 2005
End Date
April 1 2007
Last Update
March 20 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298