Pilot Study Evaluating Endoscopic Ultrasound With ShearWave Elastography for Diagnosis and Staging of Liver Fibrosis

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

The study objective is to demonstrate the clinical performance of ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS) when compared to FibroScan for evaluation of liver fibrosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: No
View:

• ≥ 18 years of age

• Willing and able to provide informed consent

• Undergoing diagnostic EUS procedure with liver biopsy

• Baseline CBC, CMP, INR within 3 months

Locations
United States
Pennsylvania
Geisinger Medical Center
Danville
Time Frame
Start Date: July 14, 2020
Completion Date: May 17, 2021
Participants
Target number of participants: 52
Treatments
Treatment Arm
Consecutive, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. Each subject will undergo both procedures (FibroScan and EUS with SW Elastography).
Authors
David Diehl, David Diehll
Related Therapeutic Areas
Sponsors
Leads: Olympus Corporation of the Americas
Collaborators: Geisinger Clinic

This content was sourced from clinicaltrials.gov

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