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Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
N/A
Recruiting
Research Sponsored by New Discovery LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two machines, iLivTouch and FibroScan, to see how well they measure liver health in adults with liver problems. The machines use sound waves to check how stiff or fatty the liver is without needing surgery.
Eligible Conditions
- Fatty Liver Disease
- Liver Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection
Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection
Secondary study objectives
Adverse events, serious events
Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI)
Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: iLivTouch then FibroScanExperimental Treatment2 Interventions
Subjects in the Group "iLivTouch then FibroScan" will be measured using iLivTouch first and then FibroScan based on the randomization result.
Group II: FibroScan then iLivTouchExperimental Treatment2 Interventions
Subjects in the Group "FibroScan then iLivTouch" will be measured using FibroScan first and then iLivTouch based on the randomization result.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iLivTouch
2022
N/A
~100
FibroScan
2009
N/A
~1090
Find a Location
Who is running the clinical trial?
Rush UniversityOTHER
45 Previous Clinical Trials
387,616 Total Patients Enrolled
Wuxi Hisky Medical Technology Co LtdIndustry Sponsor
6 Previous Clinical Trials
4,570 Total Patients Enrolled
NYU Langone HealthOTHER
1,415 Previous Clinical Trials
855,659 Total Patients Enrolled
Baylor UniversityOTHER
62 Previous Clinical Trials
65,642 Total Patients Enrolled
New Discovery LLCLead Sponsor
7 Previous Clinical Trials
2,378 Total Patients Enrolled
Stanford UniversityOTHER
2,491 Previous Clinical Trials
17,517,746 Total Patients Enrolled
Calvin Q. PanStudy ChairNew York University Langone Health