NCT03872024 - Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients | Biotech Hunter

Enrollment

180

Participants

Timeline

Start Date

September 19, 2019

Primary Completion Date

March 24, 2022

Study Completion Date

March 24, 2022

Conditions

Obesity, MorbidLiver Fibrosis

Interventions

DEVICE

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."

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)."

Trial Locations (1)

75013

Hôpital la Pitié Salpêtrière, Paris