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Amendment has done in February 2024 in Spain to include patients with high BMI above 35 kg/m². It has been decided to terminate the patient inclusions earlier (after 33 patients) due to not reilable exams and no good quality examinations
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1a: SSD<15mm and with splenomegaly | Experimental | Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly. |
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| Group 1b: SSD<15mm and without splenomegaly | Experimental | Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly. |
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| Group 2a : 15<SSD<25mm and with splenomegaly | Experimental | Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly. |
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| Group 2b : 15<SSD<25mm and without splenomegaly | Experimental | Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly. |
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| Group 3.1.a: SSD≥25mm and with splenomegaly | Experimental | Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FibroScan examination (S) | Device | A FibroScan examination with the Exploratory S probe. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert de Knegt, PhD | University Medical Center Rotterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Rotterdam | Rotterdam | Netherlands | ||||
| Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH) |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Group 3.1.b: SSD≥25mm and without splenomegaly | Experimental | Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly. |
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| 3.2 Patient with BMI >or = to 35kg/m² | Experimental | Patients with a Spleen to Skin Distance higher than 25 mm and BMI > or = to 35kg/m². |
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| FibroScan examination (M) | Device | A FibroScan examination with the Optimized M probe. |
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| FibroScan examination (XL) | Device | A FibroScan examination with the Exploratory XL probe. |
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| FibroScan examination (Standard M) | Device | A FibroScan examination with the Standard M probe. |
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| 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 |
| Cluj-Napoca |
| Romania |
| Hospital Puerta de Hierro Majadahonda | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |