Official title: Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population Using ATI / SWE / SWD: a Prospective Multicenter Study
Clinical Trial Summary
Attenuation imaging (ATI) technology independently developed by Canon medical is a
non-invasive examination technology for quantitative detection and analysis of liver
steatosis. The technique is simple, rapid and quantitative diagnosis, and is suitable for
screening and popularization of early liver steatosis in MAFLD. As noninvasive and effective
detection measures of liver inflammation and liver fibrosis, SWD and SWE are more and more
widely used in the quantitative diagnosis of liver inflammation and fibrosis. Therefore, ATI
combined with SWD / SWE detection can quantitatively diagnose different pathological stages
(steatosis, necrotizing inflammation and liver fibrosis) in the development of MAFLD, so as
to provide an important basis for treatment.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.