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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Amiens, Amiens, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Research FibroScan

Device

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).

Primary outcomes

Validity criteria of the Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) (automatically assessed by the Reference and the Research FibroScan)

Time frame: 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 outcomes

The bias between the CAPc measured with the VCTE (Reference FibroScan) and the CAPc measured by the Vibration Guided Transient Elastography (VGTE) (Research FibroScan).

Time frame: 7 months
Calculate the bias between the PCD measured by the VCTE (Reference FibroScan) and the PCD measured by the VGTE (Research FibroScan).

Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Echosens

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Feb 10, 2021
Registry last updated: Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed