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

NCT04747457 | Completed

• 1 other identifier: M138
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Liver Fibrosis

Keywords

FibroScan; Vibration Control Transient Elastography; Vibration Guided Transient Elastography; Liver Stiffness Measurement; VCTE; VGTE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Calculate the bias between the PCD measured by the VCTE (Reference FibroScan) and the PCD measured by the VGTE (Research FibroScan).

  7 months

Study Arms (1)

Adults and pediatric patients, all etiologies combined

EXPERIMENTAL

Device: Research FibroScan

Interventions

Research FibroScan DEVICE

After having obtained the patient's Informed Consent Form signature, the following 3 examinations will be done: 1. Standard examination \[Reference CE-marked FibroScan\]: the operator will need to find an optimal measurement area, and perform 10 valid measurements. 2. 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. 3. 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).

Adults and pediatric patients, all etiologies combined

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Echosens: lead

Study Sites (6)

CHU d'Amiens

Amiens, France

Location

CHU d'Angers

Angers, France

Location

CHU de Lille

Lille, France

Location

Hôpital Saint Eloi

Montpellier, France

Location

CHU de Nancy

Nancy, France

Location

CHU de Nice

Nice, France

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jérôme Boursier, Pr

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

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: February 5, 2021
• First Posted: February 10, 2021
• Study Start: April 6, 2021
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

FR (6)