Diagnosis of Fatty Liver With Outpatient Ultrasound

Liver Steatoses Clinical Trial

Official title:

Diagnosis of Fatty Liver With Outpatient Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03542578
• Other study ID #: PRO00029401
• Status: Recruiting
• Start date: September 12, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Medical College of Wisconsin
• Contact: Achuthan Sourianarayanane, MD
• Phone: 4149556850
• Email: asourianar[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will evaluate whether ultrasound performed during outpatient visit is effective in early diagnosis of fatty liver.

Description:

All patients presenting to dedicated hepatology clinic with concern for fatty liver will be evaluated by ultrasound. This will be compared with standard imaging performed for this condition. The data will be compared for effectiveness of outpatient evaluation with dedicated imaging currently practiced

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• all patients presenting to dedicated clinic

Exclusion Criteria:

• presence of ascites, inability to give consent to have study

Related Conditions & MeSH terms

• Fatty Liver
• Liver Steatoses

Intervention

Device:
• outpatient evaluation of fatty liver
outcome of ultrasound evaluation of liver in clinical outpatient settings

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outpatient ultrasound in diagnosis of fatty liver diagnosis	Effectiveness of outpatient evaluation by outpatient bedside ultrasound device in diagnosis of fatty liver compared to standard radiological evaluation. Comparing presence and severity of steatosis reported by standard radiological imaging with bed side imaging tool.	Bedside evaluation performed after consent and compared with radiological imaging perfomed within 3 months of this bedside evaluation