Optimization of Spleen VCTE Examinations with FibroScan

January 13, 2025 updated by: Echosens
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
433

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 (Standard M)
A FibroScan examination with the Standard M probe.
Device: FibroScan examination (M)
A FibroScan examination with the Optimized 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 (Standard M)
A FibroScan examination with the Standard M probe.
Device: FibroScan examination (M)
A FibroScan examination with the Optimized M probe.
Experimental: Group 3.1.a: SSD≥25mm and with splenomegaly
Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly.
Device: FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Device: FibroScan examination (XL)
A FibroScan examination with the Exploratory XL probe.
Experimental: Group 3.1.b: 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 (Standard M)
A FibroScan examination with the Standard M probe.
Device: FibroScan examination (XL)
A FibroScan examination with the Exploratory XL probe.
Experimental: 3.2 Patient with BMI >or = to 35kg/m²
Patients with a Spleen to Skin Distance higher than 25 mm and BMI > or = to 35kg/m².
Device: FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Device: FibroScan examination (M)
A FibroScan examination with the Optimized M probe.
Device: FibroScan examination (XL)
A FibroScan examination with the Exploratory XL probe.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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).
At baseline visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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).
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.
Time Frame: 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).
At baseline visit
Change of the applicability with the Spleen Targeting Tool (STT) and the automatic depth adaptation mode enabled.
Time Frame: 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.
At baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Echosens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert de Knegt, PhD, University Medical Center Rotterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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