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Clinical Trials/NCT06519331
NCT06519331RecruitingNot Applicable

M148 - Development of a New Method for Liver Stiffness Measurement Using FibroScan

Echosens4 sites in 1 country153 target enrollmentStarted: November 8, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Echosens
Enrollment
153
Locations
4
Primary Endpoint
Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 153 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult patients (≥ 18 years of age) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined.
  • •Adult patient able to give his written consent
  • •Patient affiliated to the French Social Security system

Exclusion Criteria

  • •Vulnerable patients
  • •Patients with liver ascites
  • •Patients with heart failure

Arms & Interventions

Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined

Experimental

Adult patients followed in the Hepatology or Endocrinology department for a liver disease, suspected chronic liver disease or consequences of chronic liver disease, all etiologies combined.

Intervention: Research FibroScan (FS) (Device)

Outcomes

Primary Outcomes

Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method.

Time Frame: 24 months

Secondary Outcomes

  • Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions.(24 months)
  • Bias between the different stiffness measurements (reference/estimated reference/at rest)(24 months)
  • Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan(24 months)
  • Bias between the CAP repetitions done with the Research FibroScan(24 months)

Investigators

Sponsor
Echosens
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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