Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test
|ClinicalTrials.gov Identifier: NCT01281059|
Recruitment Status : Unknown
Verified August 2011 by Hadassah Medical Organization.
Recruitment status was: Active, not recruiting
First Posted : January 21, 2011
Last Update Posted : August 28, 2012
The Exalenz clinical investigation is a multicenter, non-randomized, blinded, study of the ¹³C-Octanaote breath test (OBT). The OBT is a non-invasive test for evaluation of disease severity in patients with suspected non alcoholic fatty liver disease (NAFLD) The purpose of the study is to demonstrate that the ¹³C-Octanaote Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting non alcoholic steatohepatitis(NASH) with a high probability.
Retrospective analysis based on multivariable analysis will determined if and which demographic, clinical and biochemical or imaging techniques data can assist in addition to the data derived from OBT in differentiation of NASH, NAFL and possibly normals.
|Condition or disease||Intervention/treatment||Phase|
|NAFLD||Device: BreathID - Breath Test - 13C Octanoate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||January 2011|
U.S. FDA Resources
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281059
|Hadassah Medical Organization|