NCT03542578

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2018Dec 2026

First Submitted

Initial submission to the registry

April 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

8.3 years

First QC Date

April 24, 2018

Last Update Submit

March 8, 2026

Conditions

Liver Steatoses

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

outpatient evaluation of fatty liverDEVICE

outcome of ultrasound evaluation of liver in clinical outpatient settings

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presenting outpatient clinic will be evaluated

You may qualify if:

  • all patients presenting to dedicated clinic

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Achuthan Sourianarayanane, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Achuthan Sourianarayanane, MD

CONTACT

4149556850asourianar@mcw.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Professor

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 31, 2018

Study Start

September 12, 2018

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)