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

Overview

Información sobre este estudio

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

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Alina Allen, M.D.

Abierto para la inscripción

Contact information:

Jessica Olson

(507) 266-3995

Olson.Jessica3@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20557495

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