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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831556
• Other study ID #: Pro00071789
• Status: Completed
• Start date: July 2016
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Injuries
• Aortic Aneurysm
• Appendicitis
• Bladder Abnominalies
• Digestive System Diseases
• Diverticulitis
• Evidence of Cholecystectomy
• Gallstones
• Gastrointestinal Diseases
• Intestinal Diseases
• Intraabdominal Infections
• Intrauterine Pregnancy
• Kidney Calculi
• Kidney Stones
• Leiomyoma
• Ovarian Cysts
• Pancreatitis
• Polyps
• Pregnancy
• Pregnancy, Ectopic
• Testicular Abnominalies
• Tumors
• Uterine Abnominalies
• Uterine Fibroids
• Vascular Disease
• Vascular Diseases

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Wallace H. Coulter Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.