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

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

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

Clinical Trial Details

NCT number	NCT02831556
Study type	Observational
Source	Duke University
Contact	Joshua Broder, MD
Email	joshua.broder@duke.edu
Status	Recruiting
Phase
Start date	July 2016
Completion date	February 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.