Diagnosis of Fatty Liver With Outpatient Ultrasound
Sponsor
Medical College of Wisconsin (Other)
Overall Status
Recruiting
CT.gov ID
NCT03542578
Collaborator
(none)
500
1
57.6
8.7
Study Details
Study Description
Brief Summary
This study will evaluate whether ultrasound performed during outpatient visit is effective in early diagnosis of fatty liver.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Diagnosis of Fatty Liver With Outpatient Ultrasound
Actual Study Start Date
:
Sep 12, 2018
Anticipated Primary Completion Date
:
Jun 30, 2023
Anticipated Study Completion Date
:
Jun 30, 2023
Outcome Measures
Primary Outcome Measures
- Outpatient ultrasound in diagnosis of fatty liver diagnosis [Bedside evaluation performed after consent and compared with radiological imaging perfomed within 3 months of this bedside evaluation]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- all patients presenting to dedicated clinic
Exclusion Criteria:
- presence of ascites, inability to give consent to have study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Froedtert Hospital | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Medical College of Wisconsin
Investigators
- Principal Investigator: Achuthan Sourianarayanane, MD, Medical College of Wisconsin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Achuthan Sourianarayanane,
Asst Professor,
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT03542578
Other Study ID Numbers:
- PRO00029401
First Posted:
May 31, 2018
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: