Point of Care 3D Ultrasound for Various Applications: A Pilot Study

Summary

1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid
acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images.
The study will use a newly developed acquisition method and post-processing technique to
create three dimensional image models of the abdomen and/or pelvis.

2. Study activities and population group. The study population will be a convenience sample
of patients of any age presenting to the Emergency Department with complaints
necessitating a clinical abdominal and/or pelvic imaging. The study intervention
includes acquisition of research ultrasound images, which will not be used for clinical
care, and comparison of these images with clinically obtained images. Other clinical
data such as surgical and pathology reports will also be reviewed. 3.Data analysis and
risk/safety issues. This is a pilot study intended to determine feasibility and to
refine image reconstruction algorithms. Research images will be compared to clinical
images. Comparison of research images with final diagnosis will also occur. The research
intervention, an ultrasound exam, has no known safety risks. The only risk to subjects
is loss of confidentiality.

This study is observational, not interventional, because the experimental ultrasound will be
performed in all subjects and will not be used in the clinical care of patients
(consequently, will not have the opportunity to affect clinical outcomes). Experimental
images will be reviewed after completion of clinical care and will not be provided to the
clinicians caring for the subjects. The investigators are not measuring the effect of the
ultrasound examination on the subjects' outcomes.