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NCT06592820 · ClinicalTrials.gov registry record
Endoscopic Ultrasound Shear Wave Elastography Study
A clinical trial of MASLD and Fibrosis, Liver, sponsored by Olympus Corporation of the Americas.
- Recruiting
- Registry status
- 300
- Enrollment target
- 2
- Study locations
NCT06592820: Recruiting study of MASLD and Fibrosis, Liver, sponsored by Olympus Corporation of the Americas.
NCT06592820 is a study of MASLD and Fibrosis, Liver that is actively recruiting participants, run by Olympus Corporation of the Americas. The registered enrollment target is 300 participants, above the 71-participant average among 7 other MASLD trials with a reported enrollment target (323% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06592820, a study of MASLD and Fibrosis, Liver, is actively recruiting participants, sponsored by Olympus Corporation of the Americas.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study shall be a prospective, multicenter, single arm, consecutive, interventional 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. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\[s\] it aims to answer are: * Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis * Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores). Participants will undergo: * Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI) * Liver biopsy * FibroScan
Primary Outcome
Establish optimal cutoffs for EUS-SWE cutoffs in reference to liver biopsies on METAVIR staging system for significant fibrosis (F0-1 vs F2-4), advanced fibrosis (F0-2 vs F3-4), and cirrhosis (F0-3 vs F4) based on area under the receiver operator characteristics (AUROC) curve analysis.
Conditions Studied
Interventions
- DEVICE Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging
- DEVICE FibroScan
- DEVICE Liver biopsy
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
Pennsylvania
- Geisinger Medical Center - Danville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-09-03 |
| Est. Completion | 2027-03-28 |
What NCT06592820 shows while recruiting
NCT06592820 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 71-participant average among 7 other MASLD trials with a reported enrollment target (323% higher).
The record links to 4 conditions, with MASLD appearing as the primary indexed condition, and to 3 interventions - of which Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging is the first listed.
NCT06592820 reports a single indexed study location in Massachusetts, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06592820 about?
NCT06592820 is a clinical study titled "Endoscopic Ultrasound Shear Wave Elastography Study". This study shall be a prospective, multicenter, single arm, consecutive, interventional 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 e...
What is the current status of trial NCT06592820?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2025-09-03. Estimated completion is 2027-03-28.
What conditions does trial NCT06592820 study?
This clinical trial studies the following conditions: MASLD, Fibrosis, Liver, Chronic Liver Disease, MASH.
What interventions are being tested in trial NCT06592820?
The interventions under investigation include: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging (DEVICE), FibroScan (DEVICE), Liver biopsy (DEVICE).
Who is sponsoring clinical trial NCT06592820?
This trial is sponsored by Olympus Corporation of the Americas, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06592820 being conducted?
This trial has 2 study locations across Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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