Not a traditional drug phase: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging for MASLD
This study shall be a prospective, multicenter, single arm, consecutive, treatment study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled.
Official registry: https://clinicaltrials.gov/study/NCT06592820 · Olympus Corporation of the Americas · enrollment listed as 300
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 300 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease
Interventions: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging, FibroScan, Liver biopsy
Primary outcome (registry wording): Shear Wave Elastography (SWE) vs liver biopsy METAVIR staging system
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 18 years of age or older
- Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
- Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
Who the registry excludes
- Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma
- Prior history of Hepatitis B or C infection
- Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)
- Histological evidence of other concomitant chronic liver disease on biopsy
- Inadequate liver biopsy
- Prior history of or current excess alcohol consumption (\>140 g/week and \>210 g/week for females and males, respectively) documented in EMR
Public study contact (from the registry)
Heather Golden, MSc, CCRP
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
3 listed- Hoag Memorial Hospital — Newport Beach, California (recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts (recruiting)
- Geisinger Medical Center — Danville, Pennsylvania (recruiting)
FAQ about this NCT record
Is NCT06592820 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06592820?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06592820?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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