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

RECRUITINGSponsored by Richmond Research Institute
Actively Recruiting
SponsorRichmond Research Institute
Started2019-09-27
Est. completion2027-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

1. Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent.
2. 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.
3. An understanding, ability and willingness to fully comply with project procedures and restrictions.

For PART B only:

1\. With a known history of MASLD as evidenced either of:

1. GP diagnosis on HCF
2. Documented Fibroscan or liver US demonstrating MASLD

Exclusion Criteria:

1. Known alcoholic liver disease, history of cirrhosis of any other cause (metabolic, viral hepatitis or other)
2. Any other significant previous liver pathology (liver malignancy, portal hypertension, infiltrative liver disease)
3. Alcohol consumption \>30 units per week
4. An Implanted cardiac devices

Conditions6

Fatty LiverHealthyLiver DiseaseMASLDMASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseObesity and Obesity-related Medical Conditions

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