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

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.

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Key information

Conditions

Appendicitis Abdominal Injuries Adnexal Diseases Aneurysm Aortic Aneurysm Aortic Diseases Biliary Tract Diseases Bladder Abnominalies Calculi Cardiovascular Diseases Cecal Diseases Cholecystolithiasis Cholelithiasis Cysts Digestive System Diseases Diverticular Diseases Diverticulitis Endocrine System Diseases Evidence of Cholecystectomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gallbladder Diseases Gallstones Gastroenteritis Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Gonadal Disorders Infections Intestinal Diseases Intraabdominal Infections Intrauterine Pregnancy Kidney Calculi Kidney Diseases Kidney Stones Leiomyoma Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Nephrolithiasis Ovarian Cysts Ovarian Diseases Pancreatic Diseases Pancreatitis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Pregnancy Pregnancy Complications Pregnancy, Ectopic Testicular Abnominalies Tumors Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases Uterine Abnominalies Uterine Fibroids Vascular Disease Vascular Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

Wallace H. Coulter Foundation

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Jul 13, 2016
Registry last updated: May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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