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

Summary

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.

Conditions

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

Sponsors & Collaborators

• Wallace H. Coulter Foundation

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Joshua Broder, MD · Duke University Hospital

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2022-08-31

Completion

2022-08-31

Countries

• United States

Study Locations