Fatty Liver Imaging Project ( FLIP ) Patient Pilot Study

NCT03914482 | Withdrawn

• 1 other identifier: 6186
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 50 patients 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

Fatty Liver

Outcome Measures

Primary Outcomes (1)

• Fat concentration estimate

  The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease

  Up to 1 month following data collection

Study Arms (1)

Patients at risk of FLD

OTHER

Patients who choose to participate in the study that meet the inclusion criteria

Device: MRI

Interventions

MRI DEVICE

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

Also known as: Liver Imaging

Patients at risk of FLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients which have had at least 1 appointment with a clinician for liver function, diabetes, or obesity in the past year.
• Must be over the age of 18.
• Mild (6-26%), moderate (26-37%), or high (\>37%) level of fat in the liver that is estimated by ultrasound imaging.
• Must be proficient in English (reading/writing).

You may not qualify if:

• Any metal or electronic implants including but not limited to pacemakers, metal clips, hips.
• Pregnancy

Sponsors & Collaborators

• Aaron Fenster: lead
• Endra Lifesciences: collaborator

Study Sites (1)

University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: January 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

CA (1)