Recruiting

iLivTouch vs. FibroScan

Sponsor:

New Discovery LLC

Code:

NCT06051669

Conditions

Liver Fibrosis

Fatty Liver

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

iLivTouch

FibroScan

Study Details

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.

Conditions

Liver Fibrosis

Fatty Liver

Study ID

NCT06051669

Start date

Sep 24, 2023

Status verified date

Oct, 2023

Completion date

Mar, 2025

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

418 participants

Anticipated

Interventions and Outcome Measures

Arms

iLivTouch then FibroScan

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

FibroScan then iLivTouch

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

Interventions

iLivTouch

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

FibroScan

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

Primary outcome measure

  • Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection [ Time Frame: 6 months ]
  • Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Calvin Q Pan, Dr

(718) 888-7728Panc01@nyu.edu

Hector Ye, PA

17188880518hector.ye.pa@gmail.com

Locations

NYU Langone

Recruiting

New York, New York, United States, 11355

More Information

Sponsor

New Discovery LLC

Last update posted

Oct 13, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New Discovery LLC on 2023-10-13.