Clinical trial NCT02831556: Point of Care 3D Ultrasound for Various Applications: A Pilot Study
Official title: A Pilot Study to Test Rapid Acquisition of Point of Care Ultrasound for Various Applications
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Keywords: Ultrasound
Abdomen
Pelvis
3D
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Wallace H. Coulter Foundation
First posted: 2016-07-13
Enrollment: 174
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of any age that present to the Emergency Department with chief complaints suspected to be related to an abdominal or pelvic pathology for which clinical imaging is ordered.

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.


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

Primary outcomes:
measure: Experimental ultrasound diagnosis agreement with final reference standard diagnosis
timeFrame: 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 outcomes:
measure: Duration of experimental ultrasound exam
timeFrame: 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
measure: Experimental ultrasound image quality.
timeFrame: 4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Hospital
name: Joshua Broder, MD
role: PRINCIPAL_INVESTIGATOR
References: