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

Liver Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747457
• Other study ID #: M138
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: September 29, 2021

Study information

• Verified date: October 2021
• Source: Echosens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Fibrosis

Intervention

Device:
• Research FibroScan
After having obtained the patient's Informed Consent Form signature, the following 3 examinations will be done: Standard examination [Reference CE-marked FibroScan]: the operator will need to find an optimal measurement area, and perform 10 valid measurements. Standard examination [Research FibroScan]: the operator must take 15 valid measurements at the same measurement point as the one used for the examination with the Reference FibroScan. Exploratory examination [Research FibroScan]: the operator needs to perform15 invalid measurements to acquire data in non-optimal regions of measurement (lungs, vessels, intestines, ribs, edges of the liver).

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CHU d'Angers	Angers
France	CHU de Lille	Lille
France	Hôpital Saint Eloi	Montpellier
France	CHU de Nancy	Nancy
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Echosens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity criteria of the Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) (automatically assessed by the Reference and the Research FibroScan)	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.	7 months
Secondary	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
Secondary	Calculate the bias between the PCD measured by the VCTE (Reference FibroScan) and the PCD measured by the VGTE (Research FibroScan).		7 months