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

  • End date
    Feb 25, 2025
  • participants needed
  • sponsor
    Duke University
Updated on 25 October 2022
ct scan
safety issues
ultrasound examination
imaging techniques
surgical reconstruction
pelvic ultrasound
3d ultrasound
Accepts healthy volunteers



  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.

Condition 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
Clinical Study IdentifierNCT02831556
SponsorDuke University
Last Modified on25 October 2022


Yes No Not Sure

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
Non-patient volunteer

Exclusion Criteria

Non-English speaking
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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