Development of a New Method for Liver Stiffness Measurement Using FibroScan

NCT06519331 | Recruiting

• 1 other identifier: M148
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Diseases

Keywords

FibroScan; Vibration Controlled Transient Elastography; Liver Stiffness Measurement

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (4)

• Bias between the different stiffness measurements (reference/estimated reference/at rest)

  24 months

• Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions.

  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

Study Arms (1)

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.

Device: Research FibroScan (FS)

Interventions

Research FibroScan (FS) DEVICE

Patients #1 to #25: Exam 1: Examination with Research FibroScan. Exam 2: Examination with the Reference FibroScan at the same measurement point and with the same probe used for the Exam 1. Patients #26 to #75: Exam 1: Examination with the Research or Reference FibroScan. Exam 2: Examination with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exam 1. Patients #76 to #114: Exams 1 \& 2: 2 consecutive examinations with the Research or Reference FibroScan. Exams 3 \& 4: 2 consecutive examinations with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exams 1 \& 2.

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Echosens: lead

Study Sites (2)

Groupe Hospitalier Nord Essonne - Site Paris- Saclay

Orsay, 91400, France

RECRUITING

Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, 75013, France

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Anne Llorca

CONTACT

+33144827850; anne.llorca@echosens.com

Laura Cantu-Sanchez

CONTACT

+33144827850; laura.cantusanchez@echosens.com

Study Design

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

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

FR (2)