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NCT05728697 · ClinicalTrials.gov registry record
Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease
A clinical trial of Obesity and Non-alcoholic Fatty Liver Disease, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- 150
- Enrollment target
- 2
- Study locations
NCT05728697: Recruiting study of Obesity and Non-alcoholic Fatty Liver Disease, sponsored by Brigham and Women's Hospital.
NCT05728697 is a study of Obesity and Non-alcoholic Fatty Liver Disease that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 150 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05728697, a study of Obesity and Non-alcoholic Fatty Liver Disease, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Accuracy is measured by performing area under the receiver operator characteristic (AUROC) analysis for different threshold of liver fibrosis (e.g. advanced fibrosis, cirrhosis). The AUROC c-statistic number will then be statistically compared to other non-invasive modalities, such as FIB-4 and Fibroscan who will have similar AUROC curves generated as surrogate for accuracy.
Conditions Studied
Interventions
- DEVICE Endoscopic ultrasound shear wave elastography
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Brigham and Women's Faulkner Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2027-01 |
What NCT05728697 shows while recruiting
NCT05728697 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Endoscopic ultrasound shear wave elastography is the first listed.
NCT05728697 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05728697 about?
NCT05728697 is a clinical study titled "Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease". 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, wh...
What is the current status of trial NCT05728697?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2021-06-01. Estimated completion is 2027-01.
What conditions does trial NCT05728697 study?
This clinical trial studies the following conditions: Obesity, Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT05728697?
The interventions under investigation include: Endoscopic ultrasound shear wave elastography (DEVICE).
Who is sponsoring clinical trial NCT05728697?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05728697 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05728697's enrollment target sits among peer trials
150 370th of 1053 higher than 668 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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