Optimization of Spleen VCTE Examinations with FibroScan

Not Applicable

Terminated

• Conditions: Spleen; Fibrosis
• Interventions: Device: FibroScan examination (M); Device: FibroScan examination (XL); Device: FibroScan examination (S); Device: FibroScan examination (Standard M)

• Registration Number: NCT05122416
• Lead Sponsor: Echosens

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-16
• Study Start: 2022-06-01
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 433

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2a : 15<SSD<25mm and with splenomegaly	FibroScan examination (M)	Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly.
Group 2a : 15<SSD<25mm and with splenomegaly	FibroScan examination (Standard M)	Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly.
Group 3b: SSD≥25mm and without splenomegaly	FibroScan examination (Standard M)	Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly.
Group 1b: SSD<15mm and without splenomegaly	FibroScan examination (Standard M)	Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly.
Group 2b : 15<SSD<25mm and without splenomegaly	FibroScan examination (Standard M)	Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly.
Group 3b: SSD≥25mm and without splenomegaly	FibroScan examination (XL)	Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly.
Group 1a: SSD<15mm and with splenomegaly	FibroScan examination (S)	Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly.
Group 1a: SSD<15mm and with splenomegaly	FibroScan examination (Standard M)	Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly.
Group 2b : 15<SSD<25mm and without splenomegaly	FibroScan examination (M)	Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly.
Group 1b: SSD<15mm and without splenomegaly	FibroScan examination (S)	Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly.
Group 3a: SSD≥25mm and with splenomegaly	FibroScan examination (XL)	Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly.
Group 3a: SSD≥25mm and with splenomegaly	FibroScan examination (Standard M)	Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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).

Trial Locations

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