Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease
Recruiting · NCT04873258 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Bioimpedence Vector Analysis
What this trial is about
A generic screening study to establish structural and/or functional baselines of specific organs.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge - London, London, United Kingdom