Optimization of Spleen VCTE Examinations with FibroScan

Echosens North America

Status: Terminated

Conditions: Spleen; Fibrosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05122416

M139

Details and patient eligibility

About

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).

Enrollment: 433 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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433 participants in 7 patient groups

Group 1a: SSD<15mm and with splenomegaly

Experimental group

Description:

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

Treatment:

Device: FibroScan examination (Standard M)

Device: FibroScan examination (S)

Group 1b: SSD<15mm and without splenomegaly

Experimental group

Description:

Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly.

Treatment:

Device: FibroScan examination (Standard M)

Device: FibroScan examination (S)

Group 2a : 15<SSD<25mm and with splenomegaly

Experimental group

Description:

Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly.

Treatment:

Device: FibroScan examination (M)

Device: FibroScan examination (Standard M)

Group 2b : 15<SSD<25mm and without splenomegaly

Experimental group

Description:

Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly.

Treatment:

Device: FibroScan examination (M)

Device: FibroScan examination (Standard M)

Group 3.1.a: SSD≥25mm and with splenomegaly

Experimental group

Description:

Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly.

Treatment:

Device: FibroScan examination (Standard M)

Device: FibroScan examination (XL)

Group 3.1.b: SSD≥25mm and without splenomegaly

Experimental group

Description:

Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly.

Treatment:

Device: FibroScan examination (Standard M)

Device: FibroScan examination (XL)

3.2 Patient with BMI >or = to 35kg/m²

Experimental group

Description:

Patients with a Spleen to Skin Distance higher than 25 mm and BMI \> or = to 35kg/m².

Treatment:

Device: FibroScan examination (M)

Device: FibroScan examination (Standard M)

Device: FibroScan examination (XL)