Development of a New Method for Liver Stiffness Measurement Using FibroScan

Not Applicable

Not yet recruiting

• Conditions: Liver Diseases
• Interventions: Device: Research FibroScan (FS)

• Registration Number: NCT06519331
• Lead Sponsor: Echosens

Brief Summary

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 114 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Study Start: 2024-10-15
• Primary Completion: 2026-10-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined	Research FibroScan (FS)	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.

Primary Outcome Measures

Name	Time	Method
Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method.	24 months

Secondary Outcome Measures

Name	Time	Method
Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions.	24 months	Intra-class correlation coefficients will be done.
Bias between the different stiffness measurements (reference/estimated reference/at rest)	24 months	Correlation coefficients will be done.
Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan	24 months	Correlation coefficients will be done.
Bias between the CAP repetitions done with the Research FibroScan	24 months	Intra-class correlation coefficients will be done.

Trial Locations

Locations (2)

Groupe Hospitalier Nord Essonne - Site Paris- Saclay; 🇫🇷 Orsay, France

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, Ile De France, France