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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02831556
Other study ID # Pro00071789
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

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

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.
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