Spleen; Fibrosis
Conditions
Keywords
FibroScan, Vibration Control Transient Elastography, Spleen Stiffness Measurement
Brief summary
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).
Interventions
DEVICEFibroScan examination (S)
A FibroScan examination with the Exploratory S probe.
DEVICEFibroScan examination (M)
A FibroScan examination with the Optimized M probe.
DEVICEFibroScan examination (XL)
A FibroScan examination with the Exploratory XL probe.
DEVICEFibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Sponsors
Echosens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Adult or pediatric patient able to give written informed consent (parents/legal tutors in case of minor patients), 2. Patient affiliated to the healthcare system 3. Adult or children patient followed for a liver disease a suspicion of liver disease or for a consequence of a liver disease, with or without splenomegaly and having a spleen to skin distance (SSD) measurement performed during the screening ultrasound exam.
Exclusion criteria
1. Vulnerable patient- other than pediatric patients 2. Patients with ascites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of the spleen stiffness measurement (SSM) exam with both the optimized M+ probe and the exploratory XL+ probe, defined with at least 8 valid measurements after the exam quality control | At baseline visit | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | At baseline visit | 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). |
| 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. | At baseline visit | 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). |
| Change of the applicability with the Spleen Targeting Tool (STT) and the automatic depth adaptation mode enabled. | At baseline visit | This will be tested with unilateral Wilcoxon signed rank test comparing success rates with and without STT and with and without automatic depth adaptation. |
Countries
Netherlands, Romania, Spain
Outcome results
None listed