NCT05122416 - Optimization of Spleen VCTE Examinations with FibroScan | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

433

Conditions

Spleen; Fibrosis

Interventions

FibroScan examination (S)DEVICE

A FibroScan examination with the Exploratory S probe.

FibroScan examination (M)DEVICE

A FibroScan examination with the Optimized M probe.

FibroScan examination (XL)DEVICE

A FibroScan examination with the Exploratory XL probe.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (4)

University Medical Center Rotterdam

Rotterdam, Netherlands

Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH)

Cluj-Napoca, Romania

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Outcomes

Primary Outcomes

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).

Time frame: At baseline visit

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.