Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 1:49 PM
Study NCT ID:
NCT02652533
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2015-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
Study Overview
Official Title:
Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
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 investigators plan to investigate the use of US shear wave elastography (SWE), a newly available imaging technology, in children with suspected/known BA.
Detailed Description:
The investigators plan a prospective, multi-center study to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation can discriminate biliary atresia (BA) from other causes of liver disease in the setting of neonatal cholestasis. The investigators also plan to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation or longitudinally during the first one-year period after Kasai can predict important long-term outcomes in BA patients.
Study Oversight
Has Oversight DMC:
False
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?: