Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study

1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid
acquisition of point of care 3D ultrasound for pediatric appendicitis. The study will
use a newly developed acquisition method and post-processing technique to create three
dimensional image models of the abdomen.

2. Study activities and population group. The study population will be a convenience sample
of patients 18 years and younger with suspected appendicitis, whose clinical care
(unrelated to the study) includes ultrasound and/or CT of the abdomen. 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. If not
evident from the patient medical record, the final diagnosis will be confirmed by a
telephone call to the subject 2 weeks after the initial visit.

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 to determine the frequency of visualization of the appendix
and whether the appendix was deemed normal or abnormal. 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. We are not measuring the effect of the ultrasound
examination on the subjects' outcomes.