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Intervention study on the diagnostic capability of SmartExam

Investigation of the new computation method SmartExam of FibroScan for the diagnosis of liver steatosis and fibrosis in chronic liver diseases. - Diagnostic performance of SmartExam for chronic liver disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032220574
Enrollment
200
Registered
2023-01-18
Start date
2023-01-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver disease chronic liver disease

Interventions

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
Liver diseases, Fatty Liver, Hepatitis, Liver Cirrhosis
SmartExam, FibroScan, MRE, MRI-PDFF

Sponsors

Nogami Asako
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Comparison of diagnostic performance of conventional FS and SmartExam FS for liver steatosis using MRI-PDFF as reference

Secondary

MeasureTime frame
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 Translated with www.DeepL.com/Translator (free version)

Contacts

Public ContactAsako Nogami

Yokohama City University Graduate School of Medicine

nogamia@yokohama-cu.ac.jp+81-45-787-2640

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026