Optimization of Spleen VCTE Examinations With FibroScan

• Sponsor: Echosens (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05122416
• Collaborator: (none)
• Enrollment: 500
• Locations: 4
• Arms: 6
• Anticipated Duration (Months): 14
• Patients Per Site: 125
• Patients Per Site Per Month: 9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Spleen; Fibrosis	Device: FibroScan examination (S); Device: FibroScan examination (M); Device: FibroScan examination (XL); Device: FibroScan examination (Standard M)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Optimization of Spleen VCTE Examinations With FibroScan
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1a: SSD<15mm and with splenomegaly Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly.	Device: FibroScan examination (S); A FibroScan examination with the Exploratory S probe.; Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.
Experimental: Group 1b: SSD<15mm and without splenomegaly Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly.	Device: FibroScan examination (S); A FibroScan examination with the Exploratory S probe.; Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.
Experimental: Group 2a : 15<SSD<25mm and with splenomegaly Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly.	Device: FibroScan examination (M); A FibroScan examination with the Optimized M probe.; Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.
Experimental: Group 2b : 15<SSD<25mm and without splenomegaly Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly.	Device: FibroScan examination (M); A FibroScan examination with the Optimized M probe.; Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.
Experimental: Group 3a: SSD≥25mm and with splenomegaly Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly.	Device: FibroScan examination (XL); A FibroScan examination with the Exploratory XL probe.; Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.
Experimental: Group 3b: SSD≥25mm and without splenomegaly Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly.	Device: FibroScan examination (XL); A FibroScan examination with the Exploratory XL probe.; Device: FibroScan examination (Standard M); A FibroScan examination with the Standard M probe.

Outcome Measures

Primary Outcome Measures

1. 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 [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

1. 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).

2. 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).

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Echosens

Investigators

• Principal Investigator: Robert de Knegt, PhD, University Medical Center Rotterdam

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Echosens
• ClinicalTrials.gov Identifier: NCT05122416
• Other Study ID Numbers: M139
• First Posted: Nov 16, 2021
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Echosens: FibroScan; Vibration Control Transient Elastography; Spleen Stiffness Measurement
• Additional relevant MeSH terms: Fibrosis

Study Results

No Results Posted as of Aug 9, 2022