CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
GE ultrasound system with increased acoustic output settingsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05792423
NCT05792423N/ACompleted

Improving the Performance of Ultrasound Shear Wave Elastography (SWE) in Obese Fatty Liver Disease Patients by Developing a Conditionally Increased Output (CIO) Enhanced Ultrasound System

Massachusetts General Hospital·interventional·Posted Mar 31, 2023·Updated May 23, 2025

In Brief

A clinical study evaluating GE ultrasound system with increased acoustic output settings for Nonalcoholic Fatty Liver and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This study aims to assess possible bioeffects that may be caused by the use of shear wave elastography (SWE) with conditionally increased acoustic output pressure (CIO). Bioeffects will be monitored by of a series of liver function tests (LFTs) with results graded according to the NCI scale for drug hepatoxicity. LFTs will be collected prior to SWE imaging using CIO, as well up to 7 days post-imaging. Secondarily, this study aims to understand the degree to which SWE imaging results have improved with the use of COI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGE Healthcare

Timeline

N/ACompletedFinished
202420252026
First PostedMar 31, 2023
Enrollment StartJun 30, 2023
Primary CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.3 years ago

Interventions

GE ultrasound system with increased acoustic output settingsdevice

We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.