NCT06051669

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

September 24, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

September 1, 2023

Last Update Submit

October 11, 2023

Conditions

Liver FibrosisFatty Liver

Outcome Measures

Primary Outcomes (2)

  • Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection

    Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (LSM) between iLivTouch-FT9000 and FibroScan 530 devices.

    6 months

  • Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection

    Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.

    6 months

Secondary Outcomes (6)

  • To compare the success rate of the iLivTouch and FibroScan

    6 months

  • To compare the number of effective examinations of iLivTouch and FibroScan

    6 months

  • Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI)

    6 months

  • Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4)

    6 months

  • Liver stiffness measurement (LSM) and Steatosis-associated Fibrosis Estimator (SAFE) scores

    6 months

  • +1 more secondary outcomes

Study Arms (2)

iLivTouch then FibroScan

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

Device: iLivTouchDevice: FibroScan

FibroScan then iLivTouch

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

Device: iLivTouchDevice: FibroScan

Interventions

iLivTouchDEVICE

The examination with iLivTouch will be performed in each subject following the sequence determined by the randomization results.

FibroScan then iLivTouchiLivTouch then FibroScan
FibroScanDEVICE

The examination with FibroScan will be performed in each subject following the sequence determined by the randomization results.

FibroScan then iLivTouchiLivTouch then FibroScan

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAdults aged above 18 years old who have at least one indication for TE examination determined by the physicians
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The following conditions are considered as patient withdrawal from the current study: * Patient withdrawal of informed consent at any time during the study; * The lack of adherence to the protocol to complete the tests by two devices.

You may qualify if:

  • a. Adults aged above 18 years old who have at least one indication for TE examination determined by the physicians;
  • b. Patients who have test results for platelet count, ALT, AST, globulin, HBA1c, and total bilirubin (TBIL) levels within 60 days;
  • c. Patients who are willing to participate in the clinical study and can sign ICF.

You may not qualify if:

  • a. Excessive drinking history within 90 days: For women-140 grams of alcohol per week or more; For men-210 grams of alcohol per week or more;
  • b. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase AST \>100 U/ml (or 2.5 × upper limit of normal (ULN) and/or total bilirubin (TBIL) \> 1.8 mg/d (or \>1.5 × ULN =1.2 mg/d);
  • c. Patients with a history or current evidence of decompensated liver cirrhosis;
  • d. Patients with various space-occupying tumors and cysts in the right liver;
  • e. Patients with other serious systemically diseases or a history of malignant tumors;
  • f. Patients with ascites;
  • g. Patients with a non-healing wound on the right upper abdomen at this moment;
  • h. Patients with intracavitary implantation of instruments;
  • i. Pregnant women (urine pregnancy test should be performed for all women with child-bearing potential during screening);
  • j. Any history of organ transplantation and existing functional grafts (except corneal or hair transplantation);
  • k. Lack of or limited legal capacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University

Redwood City, California, 94305, United States

NOT YET RECRUITING

Rush University

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

NYU Langone

New York, New York, 11355, United States

RECRUITING

Baylor University

Houston, Texas, 76798, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Liver CirrhosisFatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Calvin Q. Pan

    New York University Langone Health

    STUDY CHAIR

Central Study Contacts

Calvin Q Pan, Dr

CONTACT

(718) 888-7728Panc01@nyu.edu

Hector Ye, PA

CONTACT

17188880518hector.ye.pa@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2023

First Posted

September 25, 2023

Study Start

September 24, 2023

Primary Completion

September 1, 2024

Study Completion

March 1, 2025

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations

US(4)