Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients

NCT ID: NCT03872024

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2022-03-24

Brief 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.

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.

Conditions

Obesity, Morbid; Liver Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Morbidly obese adult patients

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

Group Type: EXPERIMENTAL

For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research Model

Intervention Type: DEVICE

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 Model

Intervention Type: DEVICE

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).

Interventions

For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research Model

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.

Intervention Type: DEVICE

From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research Model

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patient with presence of ascites

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Echosens

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital la Pitié Salpêtrière

Paris, , France

Countries

France

Other Identifiers

M137

Identifier Type: -

Identifier Source: org_study_id