Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT01281059
Status:
UNKNOWN
Last Update Posted:
2012-08-28
First Post:
2011-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test
Sponsor:
Hadassah Medical Organization
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2011-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: