Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03872024
Status:
COMPLETED
Last Update Posted:
2022-08-08
First Post:
2019-02-19
Brief Title:
Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients
Sponsor:
Echosens
Organization:
Echosens
Study Overview
Official Title:
Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients - NEO Study
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 overweightmoderately 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 BMI35 kgm² 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
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 overweightmoderately 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 BMI35 kgm² 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None