Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH

NCT05120557 | Unknown DMC

• 1 other identifier: ES211
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with NASH, and to compare them to other non-invasive tests.

Conditions

Liver Diseases; Liver Cirrhosis; NASH - Nonalcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Fibrosis, Liver; Steatosis of Liver

Keywords

Elastography; Ultrasound attenuation; Sound speed; Ultrasound

Outcome Measures

Primary Outcomes (2)

• Elastography diagnostic performance

  Differences between areas under ROC curves for the ES1 liver stiffness measurement, used as a diagnostic measure of liver fibrosis severity, and other methods, in NASH patients.

  At study completion, 1 year

• Diagnostic performance estimates

  Estimates of diagnostic performances at a defined cutoff, for binary diagnostic objectives (detect ≥ F2, ≥ F3, or F4): 1. Sensitivity, specificity, and diagnostic accuracy 2. Positive and negative predictive values

  At study completion, 1 year

Secondary Outcomes (2)

• Liver stiffness robustness indicators

  At study completion, 1 year

• Equivalence with other methods

  At study completion, 1 year

Other Outcomes (3)

• Exploratory outcome 1: Liver steatosis

  At study completion, 1 year

• Exploratory outcome 2: Intra-hepatic inflammation and/or hepatocytes ballooning

  At study completion, 1 year

• Exploratory outcome 3: Liver NAS Score

  At study completion, 1 year

Study Arms (1)

Main arm

EXPERIMENTAL

Main study arm

Device: Ultrasound liver assessment

Interventions

Ultrasound liver assessment DEVICE

The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.

Also known as: Elastography, Ultrasound attenuation, Sound speed

Main arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any of the following criteria:
• Patients with known chronic liver diseases referred to liver-specific exams by their referring physician as part of the routine practice, including a VCTE exam, with or without a blood test, a MRI/MRE exam, a liver biopsy,
• Patients screened for fibrotic NASH in the context of NASH pharmaceutical trials, for which a data sharing agreement has been signed between E-Scopics and the pharmaceutical trial promoter,
• Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation,
• European patients covered by a social security program

You may not qualify if:

• 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 ES1 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.

Sponsors & Collaborators

• E-Scopics: lead

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share