Status:
COMPLETED
The EUS ShearWave Elastography Liver Fibrosis Study
Lead Sponsor:
Olympus Corporation of the Americas
Collaborating Sponsors:
Geisinger Clinic
Conditions:
Liver Fibroses
Eligibility:
All Genders
18-100 years
Brief 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.
Detailed Description
This study has been designed as prospective, single center, single arm, consecutive, blinded, pilot study conducted in a post-market setting using commercially available devices to evaluate the effect...
Eligibility Criteria
Inclusion
- ≥ 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
Exclusion
- Contraindication to EUS-guided liver biopsy
- Baseline platelet count \<50,000
- Baseline INR \>1.5
- Patient is a prisoner
Key Trial Info
Start Date :
July 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 17 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04115046
Start Date
July 14 2020
End Date
May 17 2021
Last Update
September 9 2021
Active Locations (1)
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1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-3069