NCT04747457

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Echosens · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Research FibroScan	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).

Timeline

• Start date: 2021-04-06
• Primary completion: 2021-09-29
• Completion: 2021-09-29
• First posted: 2021-02-10
• Last updated: 2021-10-13

Locations

6 sites across 1 country: France