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

NCT02831556 | Completed

• 1 other identifier: Pro00071789
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Summary

1. 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. 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.

Conditions

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

Keywords

Ultrasound; Abdomen; Pelvis; 3D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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.

Study Arms (2)

Emergency Department Subjects

Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.

Non-patient volunteers

Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of any age that present to the Emergency Department with chief complaints suspected to be related to an abdominal or pelvic pathology for which clinical imaging is ordered.

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking

Sponsors & Collaborators

• Duke University: lead
• Wallace H. Coulter Foundation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Appendicitis; Gallstones; Pregnancy, Ectopic; Aortic Aneurysm; Kidney Calculi; Diverticulitis; Abdominal Injuries; Neoplasms; Pancreatitis; Digestive System Diseases; Gastrointestinal Diseases; Intraabdominal Infections; Intestinal Diseases; Vascular Diseases; Leiomyoma; Ovarian Cysts; Polyps

Condition Hierarchy (Ancestors)

Infections; Gastroenteritis; Cecal Diseases; Cholelithiasis; Biliary Tract Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Aneurysm; Cardiovascular Diseases; Aortic Diseases; Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Diverticular Diseases; Wounds and Injuries; Pancreatic Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Cysts; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Joshua Broder, MD

  Duke University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 13, 2016
• Study Start: July 1, 2016
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)