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

Duke University

Status: Completed

Conditions: Gallstones; Uterine Fibroids; Gastrointestinal Diseases; Intestinal Diseases; Ovarian Cysts; Evidence of Cholecystectomy; Pancreatitis; Intrauterine Pregnancy; Digestive System Diseases; Kidney Stones; Pregnancy; Tumors; Bladder Abnominalies; Appendicitis; Polyps; Vascular Disease; Intraabdominal Infections; Abdominal Injuries; Aortic Aneurysm; Pregnancy, Ectopic; Diverticulitis; Uterine Abnominalies; Testicular Abnominalies

Study type: Observational

Funder types: Other

Identifiers

NCT02831556

Pro00071789

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

OR

• Non-patient volunteer

Exclusion criteria

• Non-English speaking

Trial design

174 participants in 2 patient groups

Emergency Department Subjects

Description:

Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.

Non-patient volunteers

Description:

Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.