Clinical trial NCT05122416: Optimization of Spleen VCTE Examinations with FibroScan
Official title: Optimization of Spleen VCTE Examinations with FibroScan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spleen; Fibrosis
Keywords: FibroScan
Vibration Control Transient Elastography
Spleen Stiffness Measurement
Lead sponsor: Echosens
Sponsor class: INDUSTRY
First posted: 2021-11-16
Enrollment: 433
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At baseline visit
Secondary outcomes:
measure: 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.
timeFrame: At baseline visit
measure: 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.
timeFrame: At baseline visit
measure: Change of the applicability with the Spleen Targeting Tool (STT) and the automatic depth adaptation mode enabled.
timeFrame: At baseline visit
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: University Medical Center Rotterdam
city: Cluj-Napoca
country: Romania
facility: Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH)
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: University Medical Center Rotterdam
name: Robert de Knegt, PhD
role: PRINCIPAL_INVESTIGATOR
References: