NCT05792423Completed
Conditionally Increased Output (CIO) Enhanced Ultrasound System
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
Source: ClinicalTrials.gov · Last updated 23 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 4 Jan 2023
- Start date
- 30 Jun 2023
- Primary completion date
- 31 May 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05792423
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 30 Jun 2023 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current diagnosis of drug induced liver injury
- Prior liver transplantation recipient
- Receiving drug/placebo in treatment trial now or within 30 days
- Received systemic chemotherapy within past 30 days.
- Plans to alter medication or supplement list or dosage during the study period
Other illness
- Active or recent (within 30 days) acute illness
Lab values
- Recent alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) greater than the laboratory upper limit of normal.
Other
- Excess alcohol consumption: \> 7 units/week (F) or \> 14 units/week (M)
- Confirmed or suspected pregnancy
- Pacemaker, nerve stimulator, or other implanted electronic device
- Recent ultrasound contrast administration
- Other factors that the PI considers likely to compromise study endpoints or subject safety
Who the study is looking for
- Age 18-65
- BMI 18.5-39.9
- Able to undergo abdominal ultrasound
- Able to undergo repeated blood sampling
- Stable medication and supplement list and dosing for 30 days preceding enrollment
- Willing to participate
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.