The EUS ShearWave Elastography Liver Fibrosis Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-14

Study Completion Date

2021-05-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endoscopic Ultrasound Shear Wave Elastography Study

NCT06592820

MASLD MASH Fibrosis, Liver +1 more

RECRUITING

Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

NCT04012242

Nonalcoholic Steatohepatitis Ultrasound Elastography

UNKNOWN

Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

NCT03865589

Bone Marrow Transplant Complications Sinusoidal Obstruction Syndrome Veno Occlusive Disease, Hepatic +1 more

ACTIVE_NOT_RECRUITING NA

Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.

NCT04851106

Pancreas Cancer

RECRUITING

Validation of Ultra Sound (US) Elastography

NCT02773264

Soft Tissue Lesions

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Fibroses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS)

Intervention Type DEVICE

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.

FibroScan

Intervention Type DEVICE

manufactured by Echosens

ALOKA ARIETTA 850 -

Intervention Type DEVICE

manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

FibroScan

manufactured by Echosens

Intervention Type DEVICE

ALOKA ARIETTA 850 -

manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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