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

Echosens North America

Status: Completed

Conditions: Liver Fibrosis

Treatments: Device: Research FibroScan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04747457

M138

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Adults and pediatric patients, all etiologies combined

Experimental group

Treatment:

Device: Research FibroScan