About this trial
A generic screening study to establish structural and/or functional baselines of specific organs.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent.
Willingness and ability to provide written, personally signed, and dated informed consent, in accordance with the latest ICH Good Clinical Practice (GCP) Guidelines and applicable regulations.
An understanding, ability and willingness to fully comply with project procedures and restrictions.
GP diagnosis on HCF
Disqualifiers
Known alcoholic liver disease, history of cirrhosis of any other cause (metabolic, viral hepatitis or other)
Any other significant previous liver pathology (liver malignancy, portal hypertension, infiltrative liver disease)
Alcohol consumption >30 units per week
An Implanted cardiac devices
Trial population
Adult male or female volunteers for other clinical trials taking place at the study unit.
Trial design
Cohort
Prospective
Treatments tested in this trial
Bioimpedence Vector Analysis
Diagnostic testBioimpedence vector analysis
Treatment groups
Trial outcomes
Primary outcomes
Establishment of Classification Tool for Use in Clinical Trials
The success of the final classification tool (as measured by area under the receiver operator curve (AUROC). The initial measure to generate the dataset will be the presence or absence of MASLD on liver USS.
Secondary outcomes
Normal LFT Range in NAFLD patients
The normal range of LFT's in patients with known NAFLD
Sponsors and contacts
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Richmond Research Institute
Lead sponsor
Richmond Pharmacology Limited
Collaborator