NCT03957070

The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Sonic Incytes · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.

Detailed description

This will be a prospective, open label, feasibility and validation study of the Liver Incyte system in patients with liver fibrosis (Cohort 1, n = 150) and healthy volunteers (Cohort 2, n = 50), for a total of 200 participants. The physician operator of the FibroScan, and the operator of the Shear wave vibro-elastography (S-WAVE) system, will not be blinded to the clinical diagnoses of the patients. All patients will undergo the testing with both FibroScan and Liver Incyte system at a single in-clinic visit. The liver stiffness of each participant will be assessed with the Liver Incyte Model B device and with FibroScan. The elasticity measurements from these two devices will be the primary outcome measure. The Liver Incyte system is designed as two models with differences in the ultrasound components only, description of the two models is below. Two sub-studies are included in this design as exploratory objectives. Model B will be utilized at all study sites and all study participants. Participants at the LAIR study site will also be evaluated using Model A, as well as Model B, for verification and to confirm consistency between designs. Participants will have the option to participate in the Magnetic Resonance Elastography (MRE) and Proton Density Fat Fraction (PDFF) portion of the study. MRE/PDFF is an optional procedure, which makes up a sub-study for this trial, this would require approximately 1 hour, and is open to any participant who is willing and has time for the extra study visit. The results of the MRE/PDFF sub-study will be included as an exploratory objective.

Conditions

• Liver Fibrosis
• Liver Steatosis

Interventions

Type	Name	Description
DEVICE	Liver Incyte	Ultrasound elasticity imaging

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2019-05-21
• Last updated: 2021-11-08

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study