Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592820
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-28
Brief Title:
Shear Wave Elastography Registry Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SW
Brief Summary:
This study shall be a prospective multicenter single arm consecutive blinded study conducted in a post-market setting using commercially available devices Consecutive eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis will be enrolled EUS ShearWave Elastography technology will be compared to FibroScan The data collected during this study will be evaluated in accordance with the procedures set forth in this protocol
Detailed Description:
A total of up to 300 subjects will be enrolled and treated at four US sites Enrollment is expected to be completed within 18 months Each subject will undergo both procedures FibroScan and EUS with SW Elastography End of study will be reached after pathology results have been obtained within a week of the initial procedure
This study has been designed as a post-market clinical registry to evaluate the effectiveness of Endoscopic Ultrasound with Shear Wave Elastography to estimate hepatic fibrosis in patients with chronic liver disease All consenting eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number
This study has been designed as a post-market clinical registry to evaluate the effectiveness of Endoscopic Ultrasound with Shear Wave Elastography to estimate hepatic fibrosis in patients with chronic liver disease All consenting eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number
Study Oversight
Has Oversight DMC:
None
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?:
None