Optimization of Spleen VCTE Examinations With FibroScan

Study Overview
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Brief Summary
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This is an European, prospective, interventional, and multicenter clinical investigation which main objective is to develop a spleen examination dedicated to overweight or obese patients and assess its applicability. It will take place in 4 sites (1 site in the Netherlands, 2 sites in Spain and 1 site in Romania) to include a total of 500 patients (adults and children).

Official Title
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Optimization of Spleen VCTE Examinations With FibroScan

Conditions
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Spleen; Fibrosis

Intervention / Treatment
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* Device: FibroScan examination (S)
* Device: FibroScan examination (M)
* Device: FibroScan examination (XL)
* Device: FibroScan examination (Standard M)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult or pediatric patient able to give written informed consent (parents/legal tutors in case of minor patients), Patient affiliated to the healthcare system Adult or children patient followed for a liver disease, with or without splenomegaly and having a spleen to skin distance (SSD) measurement performed during the screening ultrasound exam. Exclusion Criteria: Vulnerable patient- other than pediatric patients Patients with ascites
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be 6 different groups of patients depending on the spleen to skin distance and the presence or absence of splenomegaly. Every patient in every group will do an ultrasound and 2 FibroScan exams. The differences between Group 1 (1a and 1b), Group 2 (2a and 2b) and Group 3 (3a and 3b) are the probes that will be used to do the FibroScan.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1a: SSD<15mm and with splenomegaly<br>Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly. | Device: FibroScan examination (S)<br>* A FibroScan examination with the Exploratory S probe.<br>Device: FibroScan examination (Standard M)<br>* A FibroScan examination with the Standard M probe.<br>|
| Experimental: Group 1b: SSD<15mm and without splenomegaly<br>Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly. | Device: FibroScan examination (S)<br>* A FibroScan examination with the Exploratory S probe.<br>Device: FibroScan examination (Standard M)<br>* A FibroScan examination with the Standard M probe.<br>|
| Experimental: Group 2a : 15<SSD<25mm and with splenomegaly<br>Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly. | Device: FibroScan examination (M)<br>* A FibroScan examination with the Optimized M probe.<br>Device: FibroScan examination (Standard M)<br>* A FibroScan examination with the Standard M probe.<br>|
| Experimental: Group 2b : 15<SSD<25mm and without splenomegaly<br>Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly. | Device: FibroScan examination (M)<br>* A FibroScan examination with the Optimized M probe.<br>Device: FibroScan examination (Standard M)<br>* A FibroScan examination with the Standard M probe.<br>|
| Experimental: Group 3a: SSD≥25mm and with splenomegaly<br>Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly. | Device: FibroScan examination (XL)<br>* A FibroScan examination with the Exploratory XL probe.<br>Device: FibroScan examination (Standard M)<br>* A FibroScan examination with the Standard M probe.<br>|
| Experimental: Group 3b: SSD≥25mm and without splenomegaly<br>Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly. | Device: FibroScan examination (XL)<br>* A FibroScan examination with the Exploratory XL probe.<br>Device: FibroScan examination (Standard M)<br>* A FibroScan examination with the Standard M probe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the spleen stiffness measurement (SSM) exam with the XL probe, defined with at least 8 valid measurements after the exam quality control | The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as valid (will lead to a reliable SSM measurement) or invalid (will lead to a non-reliable SSM measurement). | At baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the spleen stiffness measurement (SSM) exam with the S probe, defined with at least 8 valid measurements after the exam quality control. | The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as valid (will lead to a reliable SSM measurement) or invalid (will lead to a non-reliable SSM measurement). | At baseline visit | 
| Success rate of the spleen stiffness measurement (SSM) exam with the optimized M probe, defined with at least 8 valid measurements after the exam quality control. | The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as valid (will lead to a reliable SSM measurement) or invalid (will lead to a non-reliable SSM measurement). | At baseline visit | 
| Change of the applicability with the Spleen Targeting Tool (STT) and the automatic depth adaptation mode enabled. | This will be tested with unilateral Wilcoxon signed rank test comparing success rates with and without STT and with and without automatic depth adaptation. | At baseline visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FibroScan, Vibration Control Transient Elastography, Spleen Stiffness Measurement