Intervention study on the diagnostic capability of SmartExam

JRCT ID: jRCT1032220574

Registered date:18/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: liver disease
• Date of first enrollment: 18/01/2023
• Target sample size: 200
• Study type: Interventional
• Intervention(s): The SmartExam FibroScan with SmartExam was loaned free of charge by Integral for research purposes and measurements were performed as an interventional study. Liver stiffness measurements are measured at least 10 times and liver steatosis will be measured at least 200 times.

Outcome(s)

• Primary Outcome: Comparison of diagnostic performance of conventional FS and SmartExam FS for liver steatosis using MRI-PDFF as reference

Secondary Outcome

1.Comparison of diagnostic performance of conventional FibroScan and SmartExam-equipped FibroScan in liver fibrosis (MRE)
2.Comparison of diagnostic performance of conventional FibroScan and SmartExam-equipped FibroScan for liver fibrosis (pathological findings)
3.Comparison of diagnostic performance of conventional FibroScan and SmartExam-equipped FibroScan in liver steatosis (pathological findings)
4.Comparison of variation in liver steatosis measurement results between the conventional FibroScan and the SmartExam-equipped FibroScan
5.Comparison of variation in liver stiffness measurement results between the conventional FibroScan and the SmartExam-equipped FibroScan
6. Correlation of liver sfiffness measurement results obtained by the conventional FibroScan and the SmartExam-equipped FibroScan
7. Correlation of liver stetosis measurement results between conventional FibroScan and SmartExam-equipped FibroScan

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Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who are 18 years of age or older at the time of enrollment
(2) Patients diagnosed with chronic liver disease by blood test or imaging test
(3) Patients who give written consent to participate in this study
(4) Patients with any type of background liver disease.

Exclude criteria

(1) Pregnant, lactating, or possibly pregnant patients
(2) Other patients who are judged to be inappropriate by the physician

Related Information

• Primary Sponsor: Nogami Asako