NCT04115046

The EUS ShearWave Elastography Liver Fibrosis Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Olympus Corporation of the Americas · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Liver Fibroses

Interventions

Type	Name	Description
DEVICE	ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS)	ShearWave Measurement is a software option available on the ARIETTA 850 that uses transient pulses to generate shear waves in the body. The tissue's elasticity is directly deduced by measuring the speed of wave propagation.
DEVICE	FibroScan	manufactured by Echosens
DEVICE	ALOKA ARIETTA 850 -	manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software

Timeline

• Start date: 2020-07-14
• Primary completion: 2021-04-26
• Completion: 2021-05-17
• First posted: 2019-10-03
• Last updated: 2021-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study