RecruitingNCT04873258

Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease

Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Volunteers on Clinical Trials Utilising Machine-learning and Bioimpedance Vector Analysis

Sponsor

Richmond Research Institute

Enrollment

2,000 participants

Start Date

Sep 27, 2019

Study Type

OBSERVATIONAL

Conditions

Healthy MASLD Obesity and Obesity-related Medical Conditions Fatty Liver MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Summary

A generic screening study to establish structural and/or functional baselines of specific organs.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

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.
For PART B only:
\. With a known history of MASLD as evidenced either of:
GP diagnosis on HCF
Documented Fibroscan or liver US demonstrating MASLD

Exclusion Criteria4

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

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