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Fatty Liver Imaging Project

NCT03757832 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-08-15

No results posted yet for this study

Summary

This study is being done to test the FLIP device, a novel device developed and manufactured by Endra Life Sciences, located in Ann Arbor, Michigan. The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease. This feasibility study will involve 25 healthy volunteers having their liver imaged by traditional ultrasound and MRI methods as well as using the FLIP device. The data obtained by the FLIP will be compared with the data obtained by ultrasound and MRI in order to determine the effectiveness of the device. This is a preliminary study to see if the investigational device could eventually be used to image the liver alongside traditional ultrasound for discerning fat concentration.

Conditions

  • Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA Device
  • Determine the Correlation of Fat Measures Obtained by the FLIP Device and Those Obtained From Quantitative MRI
  • Provide Insight Into the Sensitivity of Thermoacoustic Liver Fat Assessment With the Aim of Detecting Fat Content in Liver at 15% or Less, by Volume

Interventions

DEVICE

Liver Imaging

The device will acquire thermoacoustic data while the ultrasound probe acquires ultrasound images, and an MR of the liver is acquired as a comparative modality.

Sponsors & Collaborators

  • Aaron Fenster

    lead OTHER

Principal Investigators

  • Aaron Fenster, PhD · The University of Western Ontario

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2023-08-08
Completion
2023-08-08

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03757832 on ClinicalTrials.gov