Non-invasive Assessment of Liver Steatosis and Fibrosis New Point-Of-Care Ultrasound System Evaluation

Overview

About this study

The purpose of this study is to assess the correlation of Hepatoscope measurements with MRI-based non-invasive measurements of liver steatosis and stiffness.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients from 18 to 80 years of age.
  • Patients at risk of NAFLD-NASH referred to hepatology specialists by their referring physician for further investigation, with or without a liver biopsy.
  • Patients screened for fibrotic NASH in the context of NASH pharmaceutical trials.
  • Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation.

Exclusion Criteria:

  • Patients under 18 years of age or over 80 years of age.
  • Patients with active implants such as pacemakers, defibrillators, pumps, etc.
  • Patients presenting wounds at the location where the Hepatoscope probe shall be placed on patients’ skin.
  • Adult patients under social tutorship, or unable to provide informed consent when not subject to tutorship measures.
  • Pregnant and breastfeeding women.
  • People deprived of their freedom rights.
  • People who have been hospitalized without giving informed consent or under emergency situation.
  • People admitted in a social or sanitary institution for other reasons than the Clinical Investigation.
  • Patients included in another research study that could interfere with the present Clinical Investigation.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/20/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alina Allen, M.D., M.S.

Closed for enrollment

Contact information:

Jessica Olson

(507) 266-3995

Olson.Jessica3@mayo.edu

More information

Publications

Publications are currently not available