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

Wuxi Hisky Medical Technology

Status: Unknown

Conditions: Fatty Liver; Hepatic Steatosis; Liver Steatosis

Treatments: Device: FibroTouch; Procedure: Liver Biopsy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02456766

TG1310FT

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject at the age of 18 to 65 years, non-limited gender.
• Within two weeks of FibroTouch examination, qualified histological specimens of liver biopsy are required. Using the liver biopsy needle of 16G or 14CT, puncture and remove more than 2.0 centimeters long liver tissue (including at least 11 portal areas, no less than 6 complete portal areas and the minimum length of specimen should be more than 1.0 centimeter).
• Willing and able to abide by all principles and complete all study procedures.
• Willing and can provide written informed consent form by patient or patient's legal guardian.

Exclusion criteria

• Subject with active or suspected cancer or history of malignant tumor by evidence within 5 years before enrolling. And the subject who has the liver malignant tumors injury cannot participate in this study.
• There is evidence that the subject has a history of alcohol overdoses* or drug abuse. Definition of alcohol overdoses: 40 gram (g)/day for male and 40 g/day for female. Alcohol intake (g) = the volume of drinking (ml) × alcohol percentage (%, v/v) × 0.8 (g/ml); 1g alcohol is the equal of 25-40 ml of beer, 8-10ml of Chinese rice wine, 5-12ml of (grape) wine, 3-7ml of health care liquor or Chinese spirits.
• Subject with alcoholic liver disease and hepatitis C.
• Pregnant or nursing woman, and subject with a pregnant plan and is unwilling to take contraceptive measures during this study.
• Subject with history of organ transplantation or has functional grafts (except for the cornea or hair graft).
• Subject with non-healing wound on the right upper abdomen at this moment.
• In the investigator's opinion, the subject is unsuitable to participate in the study as he or she has a history of serious illness, or other evidence shown that the subject has any other serious illness.
• Subject who participates in other clinical trial at the same time.

Trial design

240 participants in 4 patient groups

F0

Description:

Liver Steatosis Grade: <5%

Treatment:

Procedure: Liver Biopsy

Device: FibroTouch

F1

Description:

Liver Steatosis Grade: 5-33%

Treatment:

Procedure: Liver Biopsy

Device: FibroTouch

F2

Description:

Liver Steatosis Grade: 34-66%

Treatment:

Procedure: Liver Biopsy

Device: FibroTouch

F3

Description:

Liver Steatosis Grade: > 66%

Treatment:

Procedure: Liver Biopsy

Device: FibroTouch