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

Sponsor

Duke University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02831556

Collaborator

Wallace H. Coulter Foundation (Other)

300

Enrollment

Location

103.1

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Summary

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.
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.

Condition or Disease	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Pilot Study to Test Rapid Acquisition of Point of Care Ultrasound for Various Applications

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Emergency Department Subjects Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.
Non-patient volunteers Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.

Outcome Measures

Primary Outcome Measures

Experimental ultrasound diagnosis agreement with final reference standard diagnosis [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.]

Secondary Outcome Measures

Duration of experimental ultrasound exam [The duration of the experimental ultrasound exam in seconds will be digitally recorded at the time of its performance. We anticipate the ultrasound duration to be less than 600 seconds]
Experimental ultrasound image quality. [4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.