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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||Start Date: July 2016||N/A||Observational|
Primary Outcome 1 - Measure: Experimental ultrasound diagnosis agreement with final reference standard diagnosis
Primary Outcome 1 - Time Frame: Comparison of experimental ultrasound diagnosis with final reference diagnosis will occur at approximately 4 weeks (average) after date of experimental ultrasound exam, to allow clinical follow-up to occur.
- Potential subjects must present to the emergency department for evaluation of
complaints suspected to be related to an abdominal or pelvic pathology. The clinical
diagnostic plan before subject enrollment may include abdominal or pelvic ultrasound,
CT scan and/or MRI.
- Non-patient volunteer
- Non-English speaking
Minimum Age: N/A
Maximum Age: N/A
Healthy Volunteers: Accepts Healthy Volunteers
Name: Joshua Broder, MD
Role: Principal Investigator
Affiliation: Duke University Hospital