Endra Lifesciences
The goal of this study is to use our Thermoacoustic Enhanced Ultrasound device to measure the fat levels in your liver and compare it to the the gold standard MRI PDFF measurements. Participants will have a scan with our device, then they will go have an abdominal MRI completed. The goal is to create a more accessible device to measure liver fat as it is an indicator for overall health and metabolic diseases.
The study will perform thermoacoustic fat measurements for up to 80 participants, over the span of the study. MRI-PDFF sequences will be acquired for participants in the study to establish a true measure of liver fat content, per the MRI gold standard. Determine the correlation between FLIP CID system Fat fraction results and the MRI-PDFF. Determine the accuracy between the fat measures obtained by the FLIP CID system participants who received a quantitative MRI. The following additional parameters will be evaluated endpoints: Sensitivity, Specificity ,Positive and negative predictive value (P…
Inclusion Criteria: * Study participants are 18 or older. * Able to understand, read, and provide written informed consent in English. * Able to tolerate both ultrasound and MRI examinations. * Able to lie flat, or on their side, for 20 minutes and pause breathing for up to 10 seconds. Exclusion Criteria: * Metal or electronic implants, including, but not limited to: pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices, contraindicates for MRI. * Known pregnancy the day of consent or becoming pregnant during study participation based on start date of la…
a novel Thermoacoustic Enhanced imaging device
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