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The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis

NCT03957070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-11-08

No results posted yet for this study

Summary

Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.

Conditions

  • Liver Fibrosis
  • Liver Steatosis

Interventions

DEVICE

Liver Incyte

Ultrasound elasticity imaging

Sponsors & Collaborators

  • Sonic Incytes

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2021-04-01
Completion
2021-04-01
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT03957070 on ClinicalTrials.gov