Optimization of Spleen VCTE Examinations with FibroScan

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).

Study Overview

• Status: Terminated
• Conditions: Spleen; Fibrosis
• Intervention / Treatment: Device: FibroScan examination (S); Device: FibroScan examination (Standard M); Device: FibroScan examination (M); Device: FibroScan examination (XL)

• Study Type: Interventional
• Enrollment (Actual): 433
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • University Medical Center Rotterdam
• Romania
  • Cluj-Napoca, Romania
    • Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH)
• Spain
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Puerta de Hierro Majadahonda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1a: SSD<15mm and with splenomegaly; Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly.	Device: FibroScan examination (S); A FibroScan examination with the Exploratory S probe.; Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.
Experimental: Group 1b: SSD<15mm and without splenomegaly; Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly.	Device: FibroScan examination (S); A FibroScan examination with the Exploratory S probe.; Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.
Experimental: Group 2a : 15<SSD<25mm and with splenomegaly; Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly.	Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.; Device: FibroScan examination (M); A FibroScan examination with the Optimized M probe.
Experimental: Group 2b : 15<SSD<25mm and without splenomegaly; Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly.	Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.; Device: FibroScan examination (M); A FibroScan examination with the Optimized M probe.
Experimental: Group 3.1.a: SSD≥25mm and with splenomegaly; Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly.	Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.; Device: FibroScan examination (XL); A FibroScan examination with the Exploratory XL probe.
Experimental: Group 3.1.b: SSD≥25mm and without splenomegaly; Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly.	Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.; Device: FibroScan examination (XL); A FibroScan examination with the Exploratory XL probe.
Experimental: 3.2 Patient with BMI >or = to 35kg/m²; Patients with a Spleen to Skin Distance higher than 25 mm and BMI > or = to 35kg/m².	Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.; Device: FibroScan examination (M); A FibroScan examination with the Optimized M probe.; Device: FibroScan examination (XL); A FibroScan examination with the Exploratory XL probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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

Collaborators and Investigators

• Sponsor: Echosens
• Investigators: Principal Investigator: Robert de Knegt, PhD, University Medical Center Rotterdam

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): November 22, 2024
• Study Completion (Actual): November 22, 2024

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: FibroScan; Spleen Stiffness Measurement; Vibration Control Transient Elastography
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: M139

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No