Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02831556
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
Wallace H. Coulter Foundation
Information provided by (Responsible Party):
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.


Condition or disease
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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Test Rapid Acquisition of Point of Care Ultrasound for Various Applications
Study Start Date : July 2016
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831556


Contacts
Layout table for location contacts
Contact: Joshua Broder, MD joshua.broder@duke.edu
Contact: Elias Jaffa, MD elias.jaffa@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Joshua S Broder, MD    919-681-2247    joshua.broder@duke.edu   
Principal Investigator: Joshua S Broder, MD         
Sponsors and Collaborators
Duke University
Wallace H. Coulter Foundation
Investigators
Layout table for investigator information
Principal Investigator: Joshua Broder, MD Duke University Hospital

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02831556    
Other Study ID Numbers: Pro00071789
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Duke University:
Ultrasound
Abdomen
Pelvis
3D
Additional relevant MeSH terms:
Layout table for MeSH terms
Appendicitis
Diverticulitis
Intraabdominal Infections
Leiomyoma
Ovarian Cysts
Pancreatitis
Gastrointestinal Diseases
Gallstones
Intestinal Diseases
Kidney Calculi
Pregnancy, Ectopic
Aortic Aneurysm
Vascular Diseases
Abdominal Injuries
Digestive System Diseases
Aneurysm
Cardiovascular Diseases
Pancreatic Diseases
Aortic Diseases
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Infection
Gastroenteritis
Cecal Diseases
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis