Actively Recruiting

Age: 18Years - 70Years
All Genders
ID06720766

Assessment of FibroScan in Diagnosing MASLD Among the Chinese Population With Obesity

Led by The Third People's Hospital of Chengdu · Updated on 2024-12-06

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the best way to use FibroScan, a non-invasive tool to evaluate liver fat and scarring, in Chinese people with obesity. This observational study focuses on understanding the best cut-off values for diagnosing metabolic dysfunction-associated steatotic liver disease (MASLD) in this population. The study addresses uncertainties about factors that might affect FibroScan results and aims to improve diagnosis accuracy. Participants will undergo a FibroScan examination followed by a liver biopsy within a week to compare results. This approach helps assess how well FibroScan diagnoses MASLD compared to biopsy results. The study observes patients who are scheduled for bariatric surgery and liver biopsy as part of their clinical care. During the study, researchers will collect data over approximately one year to evaluate diagnostic accuracy and determine optimal cut-off values for FibroScan in people with obesity. Participants will be monitored for liver health and related factors as part of routine clinical assessments. The study is led by The Third People's Hospital of Chengdu and does not involve experimental treatments, focusing instead on improving diagnostic methods.

CONDITIONS

Brief Title

Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older who provided written informed consent
  • Patients scheduled to undergo bariatric surgery and a liver biopsy for suspected MASLD
  • Patients scheduled to undergo FibroScan examination
Not Eligible

You will not qualify if you...

  • Patients with ascites or who are pregnant
  • Patients with any active implantable medical device such as a pacemaker or defibrillator
  • Patients who have undergone liver transplantation
  • Patients with cardiac failure and/or significant valvular disease
  • Patients with haemochromatosis
  • Patients who have refused liver biopsy or blood tests
  • Patients with active malignancy or other terminal disease
  • Patients participating in another clinical trial within the preceding 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 1 week

Participants undergo a FibroScan examination followed by a liver biopsy within a week.

2 visits (in-person)

Long-term Monitoring

Duration - Approximately 1 year

Participants are observed for diagnostic accuracy and cut-off values over the course of approximately 1 year.

Visits as scheduled for assessments

Trial Site Locations

Total: 1 location

1

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

Actively Recruiting

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Research Team

P

Peisen Guo

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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