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Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

NCT03637959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2021-12-13

Study results available
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Summary

The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.

Conditions

  • Liver Fibrosis

Interventions

DEVICE

Mechanical Vibrations with Ultrasound Shear Wave Imaging

Multiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Shigao Chen, PhD · Mayo Clinic

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-26
Primary Completion
2020-11-04
Completion
2020-11-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03637959 on ClinicalTrials.gov