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

NCT ID: NCT02831556

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 174 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2022-08-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Emergency Department Subjects

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

No interventions assigned to this group

Non-patient volunteers

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

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wallace H. Coulter Foundation

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Broder, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Hospital

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00071789

Identifier Type: -

Identifier Source: org_study_id