Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination

Not Applicable

Completed

• Conditions: Liver Fibrosis
• Interventions: Device: Research FibroScan

• Registration Number: NCT04747457
• Lead Sponsor: Echosens

Brief Summary

This is an European, prospective, interventional, and multicenter exploratory clinical investigation that will take place in 6 French sites and 200 patients will be included (adults and children). The study objective is to develop predictive indicators of homogeneous propagation of ultrasound and elastic waves to define an optimal region of interest for the measurement of liver stiffness during VCTE examination.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-04-06
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adult and pediatric patients, all etiologies combined
• Patient must be able to give written informed consent, or the parents in the case of a minor patient
• Patient affiliated to a social security system

Exclusion Criteria

• Vulnerable patient- other than pediatric patients
• Pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adults and pediatric patients, all etiologies combined	Research FibroScan	-

Primary Outcome Measures

Name	Time	Method
Validity criteria of the Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) (automatically assessed by the Reference and the Research FibroScan)	7 months	The validity criteria is an analysis of the measurement, automatically computed by the FibroScan. A measurement analyzed as "valid" leads to a reliable LSM whereas a measurement analyzed as "invalid" leads to a non-reliable LSM.

Secondary Outcome Measures

Name	Time	Method
Calculate the bias between the PCD measured by the VCTE (Reference FibroScan) and the PCD measured by the VGTE (Research FibroScan).	7 months
The bias between the CAPc measured with the VCTE (Reference FibroScan) and the CAPc measured by the Vibration Guided Transient Elastography (VGTE) (Research FibroScan).	7 months

Trial Locations

Locations (6)

CHU d'Amiens; 🇫🇷 Amiens, France

Hôpital Saint Eloi; 🇫🇷 Montpellier, France

CHU de Nancy; 🇫🇷 Nancy, France

CHU d'Angers; 🇫🇷 Angers, France

CHU de Lille; 🇫🇷 Lille, France

CHU de Nice; 🇫🇷 Nice, France