Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT06051669
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2023-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
Sponsor:
New Discovery LLC
Organization:
Study Overview
Official Title:
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US: A Multicenter, Cross-sectional, and Prospective Study
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
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:
This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients.
Detailed Description:
Clinical phase: Phase IV investigator-initiated study Study centers planned: Approximately 4 centers in different regions of the USA
Objectives:
1. Primary Objectives To evaluate the consistency of Liver Stiffness Measurement (LSM) and Ultrasound/Controlled Attenuation Parameters (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
2. Secondary Objectives
1. To compare the operational features of the two devices, reflected in the success rate of examination and number of effective examinations.
2. To compare LSM obtained from each device with liver stiffness estimated by APRI, FIB-4, and SAFE scores.
3. The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal.
Objectives:
1. Primary Objectives To evaluate the consistency of Liver Stiffness Measurement (LSM) and Ultrasound/Controlled Attenuation Parameters (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
2. Secondary Objectives
1. To compare the operational features of the two devices, reflected in the success rate of examination and number of effective examinations.
2. To compare LSM obtained from each device with liver stiffness estimated by APRI, FIB-4, and SAFE scores.
3. The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: