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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

NCT04873258

RecruitingN/A

Sponsor: Richmond Research Institute

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

Interventions: Bioimpedence Vector Analysis

Countries: United Kingdom

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

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (1)
  • London, London, United Kingdom