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

Completed

• Conditions: Gallstones; Tumors; Pancreatitis; Vascular Disease; Testicular Abnominalies; Evidence of Cholecystectomy; Pregnancy, Ectopic; Kidney Stones; Intrauterine Pregnancy; Diverticulitis

• Registration Number: NCT02831556
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-13
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States