Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US

Recruiting at 3 trial locations

Overseen By Calvin Q Pan, Dr

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New Discovery LLC

Disqualifiers: Excessive drinking, Decompensated cirrhosis, Tumors, Ascites, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

418 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Calvin Q. Pan

Principal Investigator

New York University Langone Health

Eligibility Criteria

Inclusion Criteria

You have had recent tests to measure platelet count, ALT, AST, globulin, HBA1c and total bilirubin levels.

You are willing and able to sign an Informed Consent Form (ICF) to participate in the clinical study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo liver stiffness and steatosis assessment using iLivTouch and FibroScan devices

6 months

Multiple visits for device assessments

Follow-up

Participants are monitored for adverse events and effectiveness of assessments

6 months

Treatment Details

Participant Groups

Group I: iLivTouch then FibroScan Experimental Treatment 2 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 iLivTouch Experimental Treatment 2 Interventions

Subjects in the Group "FibroScan then iLivTouch" will be measured using FibroScan first and then iLivTouch based on the randomization result.

Who Is Running the Clinical Trial?

New Discovery LLC

Lead Sponsor

Trials

8

Recruited

2,800+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

Wuxi Hisky Medical Technology Co Ltd

Industry Sponsor

Trials

8

Recruited

5,200+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Baylor University

Collaborator

Trials

65

Recruited

67,600+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+