Spleen; FibrosisNCT05122416
Optimization of Spleen VCTE Examinations with FibroScan
A study testing FibroScan examination (S), FibroScan examination (M) and FibroScan examination (XL) in people with Spleen; Fibrosis, run by Echosens at 4 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spleen; Fibrosis
- What is being tested?
- FibroScan examination (S), FibroScan examination (M) and FibroScan examination (XL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Jun 2022to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult or pediatric patient able to give written informed consent (parents/legal tutors in case of minor patients),
- Patient affiliated to the healthcare system
- 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.
Who cannot join
- Vulnerable patient- other than pediatric patients
- Patients with ascites
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 sites
Hospital Puerta de Hierro Majadahonda
Madrid
Hospital Universitario La Paz
Madrid
Romania1 site
Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH)
Cluj-Napoca
About this study
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).
- Conditions
- Spleen; Fibrosis
- Being tested
- FibroScan examination (S), FibroScan examination (M), FibroScan examination (XL), FibroScan examination (Standard M)
- Keywords
- FibroScan, Vibration Control Transient Elastography, Spleen Stiffness Measurement
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScan examination (S)Device
A FibroScan examination with the Exploratory S probe.
FibroScan examination (M)Device
A FibroScan examination with the Optimized M probe.
FibroScan examination (XL)Device
A FibroScan examination with the Exploratory XL probe.
FibroScan examination (Standard M)Device
A FibroScan examination with the Standard M probe.
| Study group | Role | What they receive |
|---|---|---|
| Group 1a: SSD<15mm and with splenomegaly | Experimental | Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly. Receives: Device: FibroScan examination (S); Device: FibroScan examination (Standard M) |
| Group 1b: SSD<15mm and without splenomegaly | Experimental | Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly. Receives: Device: FibroScan examination (S); Device: FibroScan examination (Standard M) |
| Group 2a : 15<SSD<25mm and with splenomegaly | Experimental | Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly. Receives: Device: FibroScan examination (M); Device: FibroScan examination (Standard M) |
| Group 2b : 15<SSD<25mm and without splenomegaly | Experimental | Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly. Receives: Device: FibroScan examination (M); Device: FibroScan examination (Standard M) |
| Group 3.1.a: SSD≥25mm and with splenomegaly | Experimental | Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly. Receives: Device: FibroScan examination (XL); Device: FibroScan examination (Standard M) |
| Group 3.1.b: SSD≥25mm and without splenomegaly | Experimental | Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly. Receives: Device: FibroScan examination (XL); Device: FibroScan examination (Standard M) |
| 3.2 Patient with BMI >or = to 35kg/m² | Experimental | Patients with a Spleen to Skin Distance higher than 25 mm and BMI > or = to 35kg/m². Receives: Device: FibroScan examination (M); Device: FibroScan examination (XL); Device: FibroScan examination (Standard M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: At baseline visit
Secondary outcomes (3)
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).
Measured: 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.
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).
Measured: At baseline visit
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.
Measured: At baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Jun 2022
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Why it stopped: Amendment has done in February 2024 in Spain to include patients with high BMI above 35 kg/m². It has been decided to terminate the patient inclusions earlier (after 33 patients) due to not reilable exams and no good quality examinations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spleen; FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosens
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert de Knegt, PhD, Principal investigator, University Medical Center Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122416
- Sponsor's protocol ID
- M139
- Status last verified
- Jan 2025
- First submitted
- 3 Nov 2021
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Spleen VCTE Examinations with FibroScan
- ClinicalTrials.gov ID
- NCT05122416
- Acronym / sponsor ID
- M139
- Conditions
- Spleen; Fibrosis
- Keywords
- FibroScan, Vibration Control Transient Elastography, Spleen Stiffness Measurement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amendment has done in February 2024 in Spain to include patients with high BMI above 35 kg/m². It has been decided to terminate the patient inclusions earlier (after 33 patients) due to not reilable exams and no good quality examinations
- Enrolment
- 433 participants (actual)
- Lead sponsor
- EchosensIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1a: SSD<15mm and with splenomegaly | Experimental | Device: FibroScan examination (S), Device: FibroScan examination (Standard M)Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly. |
| Group 1b: SSD<15mm and without splenomegaly | Experimental | Device: FibroScan examination (S), Device: FibroScan examination (Standard M)Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly. |
| Group 2a : 15<SSD<25mm and with splenomegaly | Experimental | Device: FibroScan examination (M), Device: FibroScan examination (Standard M)Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly. |
| Group 2b : 15<SSD<25mm and without splenomegaly | Experimental | Device: FibroScan examination (M), Device: FibroScan examination (Standard M)Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly. |
| Group 3.1.a: SSD≥25mm and with splenomegaly | Experimental | Device: FibroScan examination (XL), Device: FibroScan examination (Standard M)Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly. |
| Group 3.1.b: SSD≥25mm and without splenomegaly | Experimental | Device: FibroScan examination (XL), Device: FibroScan examination (Standard M)Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly. |
| 3.2 Patient with BMI >or = to 35kg/m² | Experimental | Device: FibroScan examination (M), Device: FibroScan examination (XL), Device: FibroScan examination (Standard M)Patients with a Spleen to Skin Distance higher than 25 mm and BMI > or = to 35kg/m². |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult or pediatric patient able to give written informed consent (parents/legal tutors in case of minor patients),
- Patient affiliated to the healthcare system
- 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.
Key exclusion criteria (2 listed)
- Vulnerable patient- other than pediatric patients
- Patients with ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroScan examination (S)A FibroScan examination with the Exploratory S probe. | Device | Group 1a: SSD<15mm and with splenomegaly, Group 1b: SSD<15mm and without splenomegaly |
| FibroScan examination (M)A FibroScan examination with the Optimized M probe. | Device | 3.2 Patient with BMI >or = to 35kg/m², Group 2a : 15<SSD<25mm and with splenomegaly, Group 2b : 15<SSD<25mm and without splenomegaly |
| FibroScan examination (XL)A FibroScan examination with the Exploratory XL probe. | Device | 3.2 Patient with BMI >or = to 35kg/m², Group 3.1.a: SSD≥25mm and with splenomegaly, Group 3.1.b: SSD≥25mm and without splenomegaly |
| FibroScan examination (Standard M)A FibroScan examination with the Standard M probe. | Device | 3.2 Patient with BMI >or = to 35kg/m², Group 1a: SSD<15mm and with splenomegaly, Group 1b: SSD<15mm and without splenomegaly, Group 2a : 15<SSD<25mm and with splenomegaly, Group 2b : 15<SSD<25mm and without splenomegaly, Group 3.1.a: SSD≥25mm and with splenomegaly, Group 3.1.b: SSD≥25mm and without splenomegaly |
Primary outcome
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).
3 secondary outcomes
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
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
Change of the applicability with the Spleen Targeting Tool (STT) and the automatic depth adaptation mode enabled.
Time frame: At baseline visit
Results and safety
The study was stopped early (reason given: Amendment has done in February 2024 in Spain to include patients with high BMI above 35 kg/m². It has been decided to terminate the patient inclusions earlier (after 33 patients) due to not reilable exams and no good quality examinations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert de Knegt, PhD principal investigator
University Medical Center Rotterdam
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibroScan examination (S), FibroScan examination (M) and FibroScan examination (XL) in people with Spleen; Fibrosis, run by Echosens at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Netherlands, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Amendment has done in February 2024 in Spain to include patients with high BMI above 35 kg/m². It has been decided to terminate the patient inclusions earlier (after 33 patients) due to not reilable exams and no good quality examinations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.