The EUS ShearWave Elastography Liver Fibrosis Study

Olympus

Status: Completed

Conditions: Liver Fibroses

Treatments: Device: ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS); Device: ALOKA ARIETTA 850 -; Device: FibroScan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04115046

2018-GI-ShearWave

Details and patient eligibility

About

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.

Full 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 effectiveness of Endoscopic Ultrasound with ShearWave Elastography to estimate hepatic fibrosis in patients with chronic liver disease. It is anticipated that the data from this study will support the need for additional clinical trials. All consenting, eligible patients reporting for an ultrasound and/or liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number. A total of 52 subjects will be enrolled and treated at a single study site in the US. Enrollment is expected to be completed within 6 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).

Enrollment: 52 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years of age
2. Willing and able to provide informed consent
3. Undergoing diagnostic EUS procedure with liver biopsy
4. Baseline CBC, CMP, INR within 3 months

Exclusion criteria

1. Contraindication to EUS-guided liver biopsy
2. Baseline platelet count <50,000
3. Baseline INR >1.5
4. Patient is a prisoner

Trial design

52 participants in 1 patient group

Treatment Arm

Description:

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).

Treatment:

Device: FibroScan

Device: ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS)

Device: ALOKA ARIETTA 850 -