Optimization of Spleen VCTE Examinations with FibroScan

NCT05122416 | Terminated

• 1 other identifier: M139
• Study Type: interventional
• Target: 433
• Locations: 3 countries
• Sites: 4

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).

Conditions

Spleen; Fibrosis

Keywords

FibroScan; Vibration Control Transient Elastography; Spleen Stiffness Measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• Change of the applicability with the Spleen Targeting Tool (STT) and the automatic depth adaptation mode enabled.

  At baseline visit

Study Arms (7)

Group 1a: SSD<15mm and with splenomegaly

EXPERIMENTAL

Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly.

Device: FibroScan examination (S); Device: FibroScan examination (Standard M)

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.

Device: FibroScan examination (S); Device: FibroScan examination (Standard M)

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.

Device: FibroScan examination (M); Device: FibroScan examination (Standard M)

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.

Device: FibroScan examination (M); Device: FibroScan examination (Standard M)

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.

Device: FibroScan examination (XL); Device: FibroScan examination (Standard M)

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.

Device: FibroScan examination (XL); Device: FibroScan examination (Standard M)

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.

Device: FibroScan examination (M); Device: FibroScan examination (XL); Device: FibroScan examination (Standard M)

Interventions

FibroScan examination (S) DEVICE

A FibroScan examination with the Exploratory S probe.

Group 1a: SSD<15mm and with splenomegaly; Group 1b: SSD<15mm and without splenomegaly

FibroScan examination (M) DEVICE

A FibroScan examination with the Optimized M probe.

3.2 Patient with BMI >or = to 35kg/m²; Group 2a : 15<SSD<25mm and with splenomegaly; Group 2b : 15<SSD<25mm and without splenomegaly

FibroScan examination (XL) DEVICE

A FibroScan examination with the Exploratory XL probe.

3.2 Patient with BMI >or = to 35kg/m²; Group 3.1.a: SSD≥25mm and with splenomegaly; Group 3.1.b: SSD≥25mm and without splenomegaly

FibroScan examination (Standard M) DEVICE

A FibroScan examination with the Standard M probe.

3.2 Patient with BMI >or = to 35kg/m²; Group 1a: SSD<15mm and with splenomegaly; Group 1b: SSD<15mm and without splenomegaly; Group 2a : 15<SSD<25mm and with splenomegaly; Group 2b : 15<SSD<25mm and without splenomegaly; Group 3.1.a: SSD≥25mm and with splenomegaly; Group 3.1.b: SSD≥25mm and without splenomegaly

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult or pediatric patient able to give written informed consent (parents/legal tutors in case of minor patients),
• Patient affiliated to the healthcare system
• 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.

You may not qualify if:

• Vulnerable patient- other than pediatric patients
• Patients with ascites

Sponsors & Collaborators

• Echosens: lead

Study Sites (4)

University Medical Center Rotterdam

Rotterdam, Netherlands

Location

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

Cluj-Napoca, Romania

Location

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert de Knegt, PhD

  University Medical Center Rotterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 16, 2021
• Study Start: June 1, 2022
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

ES (2); NL (1); RO (1)