Obesity, MorbidNCT03872024
Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients
A study testing For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research Model and From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research Model in people with Obesity, Morbid and Liver Fibrosis, run by Echosens at 1 site in France.
Trial summary
Non-Alcoholic Fatty Liver is a common clinical and histological condition associated with metabolic syndrome in patients with and without excess body weight. It represents the most common cause of liver disease in the western world and it is characterized by an excess accumulation of fatty vacuole within hepatocytes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Liver Fibrosis
- What is being tested?
- For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research Model and From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research Model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2019to 24 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be at least 18 years old
- Patient must be able to give written informed consent
- Patient affiliated to a social security system
- Patients participating in the standard bariatric surgery care program (bariatric surgery criteria defined with BMI ≥ 40 kg / m² or patients with BMI ≥ 35 kg / m² and at least 1 associated co-morbidity
Who cannot join
- Patient with presence of ascites
- Patients with exclusion criteria for bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients - NEO Study
Non-Alcoholic Fatty Liver is a common clinical and histological condition associated with metabolic syndrome in patients with and without excess body weight. It represents the most common cause of liver disease in the western world and it is characterized by an excess accumulation of fatty vacuole within hepatocytes.
Patients with non-alcoholic fatty liver disease (NAFLD) can progress to non-alcoholic steatohepatitis (NASH), and then into cirrhosis and its complications.
Read more
The prevalence of hepatic steatosis goes from 16 to 31% in the general population, from 50 to 80% in the obese population and up to 96% in morbidly obese patients. As the majority of obese individuals have NAFLD, non-invasive and widely applicable screening tools for the assessment of liver fibrosis and steatosis are needed. The detection in early stages is the main predictive factor of the long-term outcome.
Liver biopsy has traditionally been the gold standard for the assessment of patients with NAFLD, although the well-known limitations. Among the non-invasive tools available in the market, the FibroScan® (Echosens™, Paris, France) has been shown to be a useful tool for diagnosing fibrosis and steatosis in patients with suspected NAFLD. The FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM) and the controlled attenuation parameter (CAP).
Several clinical studies have shown the benefit of measuring hepatic stiffness with the FibroScan® in overweight/moderately obese persons. The ability to identify significant fibrosis and cirrhosis has been demonstrated in normal and overweight patients affected with chronic hepatitis B and C, biliary diseases, alcohol related liver disease and NAFLD.
However, subcutaneous fat attenuates the transmission of shear waves into the liver and the ultrasonic signals used to measure their speed of propagation. When scanning morbidly obese patients (BMI≥35 kg/m²) with the XL+ probe, unreliable results occur mainly due to obesity. Therefore, the XL probe has been enabled to expand the applicability of the FibroScan® but, the realization of the XL+ examination is still very difficult in the case of morbidly obese patients. This is why to reduce this failure rate, Echosens has worked on developing the XXL probe specifically for measuring the LSM in morbidly obese patients.
- Conditions
- Obesity, Morbid, Liver Fibrosis
- Being tested
- For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research Model, From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research Model
- Medical subject headings
- Obesity, Morbid, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research ModelDevice
After the patient informed consent form signature and during the patient pre-operative routine hospitalization, the following examinations will be done:
- An ultrasound examination
- One examination with the FibroScan® 430 mini fitted with the XL+ probe (commercial reference)
- Three examinations with the FibroScan® 630 Expert - Research model fitted with the 3 XXL probe prototypes.
From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research ModelDevice
After the patient informed consent form signature and during the patient pre-operative routine hospitalization, the following examinations will be done:
- An ultrasound examination
- One examination with the FibroScan® 430 mini fitted with the XL+ probe (commercial reference)
- One examination with the FibroScan® 630 Expert - Research model fitted with 1 adjusted XXL+ probe prototype (H+F prototype probe).
| Study group | Role | What they receive |
|---|---|---|
| Morbidly obese adult patients | Experimental | Only one group of patients in the study: morbidly obese adult patients who will have an examination with the XXL probe prototype of the FibroScan 630 Research Model Receives: Device: For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research Model; Device: From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver biopsy: fibrosis stage from F0 to F4 with Kleiner (NASH CRN) scoring system
A liver biopsy will be performed during the bariatric surgery and will be sent to a centralized pathologist that will quantify the fibrosis and classify it from F0 to F4. Where F0 indicates the absence of fibrosis and F4 indicates cirrhosis.
Measured: 12 months
Secondary outcomes (4)
Number of valid measurements per probe higher than 8
In order to be considered as a reliable exam, at least 8 valid measurements should be taken by the XL probe and the XXL prototype probes. Invalid measurements can appear when the probe connected to the FibroScan can't take a measurement for different reasons (distance skin to capsule very big, not good positioning of the probe….).
Measured: 12 months
Liver Stiffness Measurement (LSM) from 1.5 to 75 kPa assessed with the FibroScan
The FibroScan stiffness measurement relies on the propagation of elastic waves to assess the stiffness of the liver: the faster elastic waves propagates within the liver, the stiffer the organ is. The final LSM value is the median of individual LSM values using the valid measurements and is expressed in kilo Pascal (kPa). Values obtained for the LSM with every probe will be assessed.
Measured: 12 months
Controlled Attenuation Parameter (CAP) from 100 to 400 dB/m, assessed with the FibroScan
The intensity of ultrasonic signals received by the probe, which decrease as a function of depth and according to the medium, is measured:the CAP is the ultrasonic attenuation rate and is expressed in decibel per meter (dB/m). Values obtained for the CAP with every probe will be assessed.
Measured: 12 months
Liver biopsy: steatosis grade from S0 to S3 with Kleiner (NASH CRN) scoring system
Measure and classify the steatosis grade (fat in the liver) by analyzing the liver biopsy. Where S0 represents the minimal steatosis grade (<5% hépatocytes with fat) and S3 indicates a steatosis with >66% hépatocytes with fat.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start19 Sep 2019
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosens
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872024
- Sponsor's protocol ID
- M137
- Status last verified
- Aug 2022
- First submitted
- 19 Feb 2019
- Last updated
- 8 Aug 2022
- 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients - NEO Study
- ClinicalTrials.gov ID
- NCT03872024
- Acronym / sponsor ID
- M137
- Conditions
- Obesity, Morbid, Liver Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- EchosensIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 12 Mar 2019 (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.
Non-Alcoholic Fatty Liver is a common clinical and histological condition associated with metabolic syndrome in patients with and without excess body weight. It represents the most common cause of liver disease in the western world and it is characterized by an excess accumulation of fatty vacuole within hepatocytes.
Patients with non-alcoholic fatty liver disease (NAFLD) can progress to non-alcoholic steatohepatitis (NASH), and then into cirrhosis and its complications.
The prevalence of hepatic steatosis goes from 16 to 31% in the general population, from 50 to 80% in the obese population and up to 96% in morbidly obese patients. As the majority of obese individuals have NAFLD, non-invasive and widely applicable screening tools for the assessment of liver fibrosis and steatosis are needed. The detection in early stages is the main predictive factor of the long-term outcome.
Liver biopsy has traditionally been the gold standard for the assessment of patients with NAFLD, although the well-known limitations. Among the non-invasive tools available in the market, the FibroScan® (Echosens™, Paris, France) has been shown to be a useful tool for diagnosing fibrosis and steatosis in patients with suspected NAFLD. The FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM) and the controlled attenuation parameter (CAP).
Several clinical studies have shown the benefit of measuring hepatic stiffness with the FibroScan® in overweight/moderately obese persons. The ability to identify significant fibrosis and cirrhosis has been demonstrated in normal and overweight patients affected with chronic hepatitis B and C, biliary diseases, alcohol related liver disease and NAFLD.
However, subcutaneous fat attenuates the transmission of shear waves into the liver and the ultrasonic signals used to measure their speed of propagation. When scanning morbidly obese patients (BMI≥35 kg/m²) with the XL+ probe, unreliable results occur mainly due to obesity. Therefore, the XL probe has been enabled to expand the applicability of the FibroScan® but, the realization of the XL+ examination is still very difficult in the case of morbidly obese patients. This is why to reduce this failure rate, Echosens has worked on developing the XXL probe specifically for measuring the LSM in morbidly obese patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morbidly obese adult patients | Experimental | Device: For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research Model, Device: From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research ModelOnly one group of patients in the study: morbidly obese adult patients who will have an examination with the XXL probe prototype of the FibroScan 630 Research Model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be at least 18 years old
- Patient must be able to give written informed consent
- Patient affiliated to a social security system
- Patients participating in the standard bariatric surgery care program (bariatric surgery criteria defined with BMI ≥ 40 kg / m² or patients with BMI ≥ 35 kg / m² and at least 1 associated co-morbidity
Key exclusion criteria (2 listed)
- Patient with presence of ascites
- Patients with exclusion criteria for bariatric surgery
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 |
|---|---|---|
| For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research ModelAfter the patient informed consent form signature and during the patient pre-operative routine hospitalization, the following examinations will be done: * An ultrasound examination * One examination with the FibroScan® 430 mini fitted with the XL+ probe (commercial reference) * Three examinations with the FibroScan® 630 Expert - Research model fitted with the 3 XXL probe prototypes. | Device | Morbidly obese adult patients |
| From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research ModelAfter the patient informed consent form signature and during the patient pre-operative routine hospitalization, the following examinations will be done: * An ultrasound examination * One examination with the FibroScan® 430 mini fitted with the XL+ probe (commercial reference) * One examination with the FibroScan® 630 Expert - Research model fitted with 1 adjusted XXL+ probe prototype (H+F prototype probe). | Device | Morbidly obese adult patients |
Primary outcome
Liver biopsy: fibrosis stage from F0 to F4 with Kleiner (NASH CRN) scoring system
Time frame: 12 months
A liver biopsy will be performed during the bariatric surgery and will be sent to a centralized pathologist that will quantify the fibrosis and classify it from F0 to F4. Where F0 indicates the absence of fibrosis and F4 indicates cirrhosis.
4 secondary outcomes
Number of valid measurements per probe higher than 8
Time frame: 12 months
Liver Stiffness Measurement (LSM) from 1.5 to 75 kPa assessed with the FibroScan
Time frame: 12 months
Controlled Attenuation Parameter (CAP) from 100 to 400 dB/m, assessed with the FibroScan
Time frame: 12 months
Liver biopsy: steatosis grade from S0 to S3 with Kleiner (NASH CRN) scoring system
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research Model and From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research Model in people with Obesity, Morbid and Liver Fibrosis, run by Echosens at 1 site 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 4 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: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Liver biopsy: fibrosis stage from F0 to F4 with Kleiner (NASH CRN) scoring system (time frame: 12 months). 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 8 Aug 2022.