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Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis

NCT02456766 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2015-05-28

No results posted yet for this study

Summary

This will be a multi-center, prospective, controlled study. It is expected that about 240 subjects from 10 study centers will be enrolled, and 224 effective subjects will be statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56 effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56 effective subjects with stage F3 (25%). By comparison of the result of FibroTouch examination with that of liver biopsy, their specificities, sensitivities and accuracies for diagnosis of liver steatosis will be identified.

The patients with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.

Conditions

Interventions

DEVICE

FibroTouch

PROCEDURE

Liver Biopsy

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Guangzhou First People's Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • No.85 Hospital, Changning, Shanghai, China

    collaborator OTHER

  • The Second Hospital of Nanjing Medical University

    collaborator OTHER

  • Sichuan Academy of Medical Sciences

    collaborator OTHER

  • Second People's Hospital of Hangzhou

    collaborator UNKNOWN

  • Wuxi Hisky Medical Technology Co Ltd

    lead INDUSTRY

Principal Investigators

  • Lungen LU, MD · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT02456766 on ClinicalTrials.gov