No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
150 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for adults with obesity and non-alcoholic fatty liver disease. Participants will undergo an endoscopic ultrasound that includes a quick additional test called shear wave elastography, which helps assess liver health without added risk.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I need an endoscopic ultrasound for medical reasons
I have suspected or confirmed non-alcoholic fatty liver disease
My body mass index is 25 or higher
You may not be able to join if
I have an inadequate liver biopsy sample
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this observation study is to assess whether endoscopic ultrasound shear wave elastography (EUS-SWE) may be a useful tool for liver fibrosis screening in patients with elevated body mass index and non alcoholic fatty liver disease as compared to other non-invasive screening modalities, which have traditionally had less accurate results in this population.
The main questions it aims to …
The goal of this observation study is to assess whether endoscopic ultrasound shear wave elastography (EUS-SWE) may be a useful tool for liver fibrosis screening in patients with elevated body mass index and non alcoholic fatty liver disease as compared to other non-invasive screening modalities, which have traditionally had less accurate results in this population.
The main questions it aims to answer are:
* Determine accuracy of EUS-SWE for liver fibrosis screening compared to other non-invasive scoring systems, such as the FIB-4 score and Fibroscan in patients with elevated body mass index
* Establish optimal stiffness (kPa) cutoffs for liver fibrosis grading for EUS-SWE for this patient population in reference to the gold standard liver biopsy, as no standard cutoffs currently exist.
Participants will undergo routine endoscopic ultrasound as part of their standard clinical care and indication. Participants are consented for the procedure and undergoing the shear wave elastography. In addition to their standard ultrasound test, it takes on average an extra 2-3 minutes to perform the shear wave elastography. The procedure itself adds no additional risk to the patient and does not expose them to radiation.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults 18 years or older
* Planned for clinically indicated endoscopic ultrasound with plan for follow up liver biopsy
* Suspected or confirmed non alcoholic fatty liver disease prior to procedure
* Body mass index \>=25
Exclusion Criteria:
* Inadequate liver biopsy sample
Inclusion Criteria:
* Adults 18 years or older
* Planned for clinically indicated endoscopic ultrasound with plan for follow up liver biopsy
* Suspected or confirmed non alcoholic fatty liver disease prior to procedure
* Body mass index \>=25
Exclusion Criteria:
* Inadequate liver biopsy sample
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