UMIN ID: UMIN000054302
Registered date:01/05/2024
Clinical Trial on Artificial Intelligence (AI) Assisted System for Diagnosis of Liver Lipidosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | non-alcoholic fatty liver |
| Date of first enrollment | 2022/04/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Abdominal ultrasound and MRI examinations are performed after consent forms are obtained. Abdominal ultrasound qualitatively and quantitatively evaluates the degree of liver fibrosis and lipidosis, while MRI quantifies and evaluates the amount of fat in the liver. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 100years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients with tattoos or MRI-unsuitable metal in the body 2) Pregnant or lactating women, or patients who may be pregnant or intend to become pregnant (a pregnancy reaction test should be performed if pregnancy is suspected). 3) Patients with other conditions that may compromise patient safety in the conduct of the study or make it difficult to comply with the study protocol. |
Related Information
| Primary Sponsor | Chiba university hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Non |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hidemi Unozawa |
| Address | 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba Japan 260-8677 |
| Telephone | 0432227171 |
| unozawa.hidemi@chiba-u.jp | |
| Affiliation | Chiba University Hospital gastroenterology |
| scientific contact | |
| Name | Naoya Kato |
| Address | 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba Japan |
| Telephone | 0432227171 |
| unozawa.hidemi@chiba-u.jp | |
| Affiliation | Chiba University Hospital gastroenterology |