Metabolic Syndrome XACOUSTIQNCT06661655
Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
A study testing Liver ultrasound in people with Metabolic Syndrome X and Fatty Liver, run by E-Scopics at 3 sites in France.
Trial summary
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Syndrome X, Fatty Liver, MASH - Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- Liver ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Jul 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient below 80 yo
- Patients with MASLD/MASH recruited in interventional trials requiring MRI PDFF +/- MRE per interventional protocol, OR
- Patients with MASLD/MASH recruited in prospective cohorts requiring MRI PDFF +/- MRE per interventional protocol, OR
- Patients referred to MRI-PDFF or MRE.
- Patients who consented in written to participate in the study
- Patients with ongoing social security coverage
Who cannot join
- Patient in their minority (less than 18 yo) or older than 80 yo,
- Patient with active implants,
- Patient presenting with a wound where the Hepatoscope exam shall be performed (abdominal right upper quadrant)
- Patient with a history of decompensated cirrhosis,
- Patient with a history of hepatocellular carcinoma,
- Adult patient under tutorship, or unable to express informed consent,
Show all 10Show fewer
- Pregnant or breast-feeding
- Person deprived from their liberty
- Patient hospitalized without providing consent or in case of an emergency
- Patient presenting with another know liver disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
University Hospital Angers
Angers, 49933
Jerome Boursier, MD, PhD, +33 2 41 35 31 42, jeboursier@chu-angers.fr
Jerome Boursier, MD PhD
- Recruiting
Beaujon University Hospital
Clichy, 92110
Laurent Castera, MD, PhD, +33 1 40 87 55 24, laurent.castera@aphp.fr
Laurent Castera, MD, PhD
- Not yet recruiting
Pitie Salpetriere University Hospital
Paris, 75013
Raluca Pais, MD, +33 1 42 16 10 34, raluca.pais@aphp.fr
Raluca Pais, MD
About this study
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.
Read the detailed description
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI PDFF.
The primary objective is to compare ultrasound parameters measurements of ultrasound attenuation, backscattering coefficient and sound speed to the hepatic fat fraction as measured with MRI-PDFF.
The secondary objectives includes the comparison of measurements of quantitative ultrasound parameters between Hepatoscope and FibroScan, and to compare the measurement of liver stiffness between Hepatoscope and MRE.
Exploratory objectives have been determined to allow the comparison of said measured parameters to the outcome of histopathological analysis in a subset patient population who would benefit from a liver biopsy.
- Conditions
- Metabolic Syndrome X, Fatty Liver, MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD, NASH (Non-Alcoholic Steatohepatitis), Steatosis, Liver
- Being tested
- Liver ultrasound
- Keywords
- Liver, Fibrosis, Steatosis, Elastography, Ultrasound, Attenuation, Backscattering coefficient, Sound speed, MRI PDFF, Hepatoscope
- Medical subject headings
- Metabolic Syndrome, Fatty Liver, Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver ultrasoundDevice
Hepatoscope is a point of care ultraportable ultrasound device that is capable of conventional grayscale ultrasound imaging, of 2D transient elastography (imaging + liver stiffness measurement), and of quantitative ultrasound properties measurement (ultrasound attenuation, backscattering coefficient, sound speed) related to liver steatosis.
| Study group | Role | What they receive |
|---|---|---|
| Main cohort | Experimental | Patients recruited in the study will receive an ultrasound exam with Hepatoscope to collect quantitative measurements related to the severity of liver steatosis. Receives: Device: Liver ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation with MRI PDFF
Spearman correlation coefficients between each Hepatoscope measurement (ATT, BSC and SOS) and MRI-PDFF measurements will be calculated. The confidence interval will be estimated with an alpha risk of 0,017 (Bonferroni adjustment, overal alpha risk of 0,05). Each correlation will be compared to the lowest acceptable threshold D = 0,50 with a Fisher Z test, with an alpha risk de 0,017.
Measured: At a maximum of 6 months from enrollment
Secondary outcomes (1)
Comparison with Fibroscan CAP
Spearman correlations between Hepatoscope measurements and MRI-PDFF will be compared to Spearman correlations between Fibroscan CAP measurements and MRI-PDFF. The 95% confidence interval of each correlation will be estimated and compared to each other using a Fisher Z test with an alpha risk of 0,05.
Measured: At a maximum of 6 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start24 Jul 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross sectional investigation
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-Scopics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claude Cohen-Bacrie, Study director, E-ScopicsJerome Boursier, MD, PhD, Study chair, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661655
- Sponsor's protocol ID
- ES213
- Other IDs
- 2023-A02456-39
- Acronym
- ACOUSTIQ
- Status last verified
- Aug 2025
- First submitted
- 24 Oct 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified individual participant data may be shared, limited to data collected in CRF
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
- ClinicalTrials.gov ID
- NCT06661655
- Acronym / sponsor ID
- ACOUSTIQ / ES213
- Conditions
- Metabolic Syndrome X, Fatty Liver, MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD, NASH (Non-Alcoholic Steatohepatitis), Steatosis, Liver
- Keywords
- Liver, Fibrosis, Steatosis, Elastography, Ultrasound, Attenuation, Backscattering coefficient, Sound speed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- E-ScopicsIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 Oct 2024 (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.
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.
Detailed description
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI PDFF.
The primary objective is to compare ultrasound parameters measurements of ultrasound attenuation, backscattering coefficient and sound speed to the hepatic fat fraction as measured with MRI-PDFF.
The secondary objectives includes the comparison of measurements of quantitative ultrasound parameters between Hepatoscope and FibroScan, and to compare the measurement of liver stiffness between Hepatoscope and MRE.
Exploratory objectives have been determined to allow the comparison of said measured parameters to the outcome of histopathological analysis in a subset patient population who would benefit from a liver biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross sectional investigation
| Arm | Type | Receives |
|---|---|---|
| Main cohort | Experimental | Device: Liver ultrasoundPatients recruited in the study will receive an ultrasound exam with Hepatoscope to collect quantitative measurements related to the severity of liver steatosis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient below 80 yo
- Patients with MASLD/MASH recruited in interventional trials requiring MRI PDFF +/- MRE per interventional protocol, OR
- Patients with MASLD/MASH recruited in prospective cohorts requiring MRI PDFF +/- MRE per interventional protocol, OR
- Patients referred to MRI-PDFF or MRE.
- Patients who consented in written to participate in the study
Key exclusion criteria (10 listed)
- Patient in their minority (less than 18 yo) or older than 80 yo,
- Patient with active implants,
- Patient presenting with a wound where the Hepatoscope exam shall be performed (abdominal right upper quadrant)
- Patient with a history of decompensated cirrhosis,
- Patient with a history of hepatocellular carcinoma,
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 |
|---|---|---|
| Liver ultrasoundHepatoscope is a point of care ultraportable ultrasound device that is capable of conventional grayscale ultrasound imaging, of 2D transient elastography (imaging + liver stiffness measurement), and of quantitative ultrasound properties measurement (ultrasound attenuation, backscattering coefficient, sound speed) related to liver steatosis. | Device | Main cohort |
Primary outcome
Correlation with MRI PDFF
Time frame: At a maximum of 6 months from enrollment
Spearman correlation coefficients between each Hepatoscope measurement (ATT, BSC and SOS) and MRI-PDFF measurements will be calculated. The confidence interval will be estimated with an alpha risk of 0,017 (Bonferroni adjustment, overal alpha risk of 0,05). Each correlation will be compared to the lowest acceptable threshold D = 0,50 with a Fisher Z test, with an alpha risk de 0,017.
1 secondary outcome
Comparison with Fibroscan CAP
Time frame: At a maximum of 6 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: Yes. Only de-identified individual participant data may be shared, limited to data collected in CRF
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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.
Claude Cohen-Bacrie study director
E-Scopics
Jerome Boursier, MD, PhD study chair
University Hospital, Angers
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver ultrasound in people with Metabolic Syndrome X and Fatty Liver, run by E-Scopics at 3 sites in France.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerome Boursier, MD, PhD (+33 2 41 35 31 42, jeboursier@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation with MRI PDFF (time frame: At a maximum of 6 months from enrollment). 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 Aug 2025.