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Prospective pilotstudy for the development and evaluation of softwaretools for non-invasive assessment of fibrosis and steatosis of the liver with machine learning methods

Prospective pilotstudy for the development and evaluation of softwaretools for non-invasive assessment of fibrosis and steatosis of the liver with machine learning methods

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00022509
Enrollment
80
Registered
2020-11-26
Start date
2021-03-17
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K76.0

Interventions

Group 1: Single arm pilotstudy. Within this prospective, monocentric pilotstudy 80 patients with non-alcoholic fatty liver disease or steatohepatitis (NAFLD/NASH) will be recruited in the outpatient c

Sponsors

Goethe-Universität Frankfurt am Main
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of a non-alcoholic fatty liver disease

Exclusion criteria

Exclusion criteria: - Alcohol consumption = 20 g/d in female and = 30 g/d in male patients - Decompensated cirrhosis of the liver - Viral hepatitis - Non-viral primary or secondary liver diseases other than NAFLD/NASH - Malignancies (except for basalioma) within the last 5 years, in particular primary or secondary liver tumors - Orthotopic liver transplantation - Any comedication known to cause hepatic steatosis (i.e. steroids, Methotrexate, Amiodarone, Tamoxifen, Valproate, Flutamide, etc.) - Clinically relevant heart insufficiency, cardiac arrhythmias, relevant cardiac valve diseases - Pregnancy and lactation

Design outcomes

Primary

MeasureTime frame
The aim of this pilot study is to establish an algorithm based on ultrasound raw data for the assessment of liver fibrosis and steatosis with methods of machine learning.

Secondary

MeasureTime frame
Not applicable.

Countries

Germany

Contacts

Public ContactUlrike Mihm

Universitätsklinikum Frankfurt Medizinische Klinik 1

ulrike.mihm@kgu.de069-6301-5122

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026