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

• Sponsor: Echosens (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04747457
• Collaborator: (none)
• Enrollment: 200
• Locations: 6
• Arm: 1
• Actual Duration (Months): 5.8
• Patients Per Site: 33.3
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Fibrosis	Device: Research FibroScan	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination
• Actual Study Start Date: Apr 6, 2021
• Actual Primary Completion Date: Sep 29, 2021
• Actual Study Completion Date: Sep 29, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Adults and pediatric patients, all etiologies combined

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).

Outcome Measures

Primary Outcome Measures

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

1. 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]

2. Calculate the bias between the PCD measured by the VCTE (Reference FibroScan) and the PCD measured by the VGTE (Research FibroScan). [7 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU d'Amiens	Amiens		France
2	CHU d'Angers	Angers		France
3	CHU de Lille	Lille		France
4	Hôpital Saint Eloi	Montpellier		France
5	CHU de Nancy	Nancy		France
6	CHU de Nice	Nice		France

Sponsors and Collaborators

• Echosens

Investigators

• Principal Investigator: Jérôme Boursier, Pr, University Hospital, Angers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Echosens
• ClinicalTrials.gov Identifier: NCT04747457
• Other Study ID Numbers: M138
• First Posted: Feb 10, 2021
• Last Update Posted: Oct 13, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Echosens: FibroScan; Vibration Control Transient Elastography; Vibration Guided Transient Elastography; Liver Stiffness Measurement; VCTE; VGTE
• Additional relevant MeSH terms: Liver Cirrhosis

Study Results

No Results Posted as of Oct 13, 2021