Optimization of Spleen VCTE Examinations With FibroScan

Spleen; Fibrosis Clinical Trial

Official title:

Optimization of Spleen VCTE Examinations With FibroScan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122416
• Other study ID #: M139
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2022
• Source: Echosens
• Contact: Anne Llorca
• Phone: +33144827850
• Email: anne.llorca[@]echosens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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, 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

Related Conditions & MeSH terms

• Fibrosis
• Spleen; Fibrosis

Intervention

Device:
• FibroScan examination (S)
A FibroScan examination with the Exploratory S probe.
• FibroScan examination (M)
A FibroScan examination with the Optimized M probe.
• FibroScan examination (XL)
A FibroScan examination with the Exploratory XL probe.
• FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.

Locations

Country	Name	City	State
Netherlands	University Medical Center Rotterdam	Rotterdam
Romania	Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH)	Cluj-Napoca
Spain	Hospital Puerta de Hierro Majadahonda	Madrid
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Echosens

Countries where clinical trial is conducted

Netherlands,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of the spleen stiffness measurement (SSM) exam with the 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	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).	At baseline visit
Secondary	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).	At baseline visit
Secondary	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.	At baseline visit