Point of Care 3D Ultrasound for Various Applications: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT02831556|
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : January 30, 2020
- 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|
|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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||A Pilot Study to Test Rapid Acquisition of Point of Care Ultrasound for Various Applications|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||February 2025|
Emergency Department Subjects
Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.
Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.
- Experimental ultrasound diagnosis agreement with final reference standard diagnosis [ Time Frame: 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. ]
- Duration of experimental ultrasound exam [ Time Frame: 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. [ Time Frame: 4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831556
|Contact: Joshua Broder, MDfirstname.lastname@example.org|
|Contact: Elias Jaffa, MDemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Joshua S Broder, MD 919-681-2247 firstname.lastname@example.org|
|Principal Investigator: Joshua S Broder, MD|
|Principal Investigator:||Joshua Broder, MD||Duke University Hospital|