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CompletedNCT02831556Updated May 21, 2024

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

An observational study in Appendicitis, Evidence of Cholecystectomy and Gallstones, sponsored by Duke University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by Duke University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
174
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's enrollment of 174 is below the median of 200 across 151 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Non-English speaking
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
174 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  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 outcomes

  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.

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2016, a primary completion of Aug 2022 and a completion of Aug 2022. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2016
First posted
Jul 13, 2016
Start
Jul 2016
Primary completionActual
Aug 31, 2022
CompletionActual
Aug 31, 2022
Last update
May 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02831556
Lead sponsor
Duke University
Collaborators
Wallace H. Coulter Foundation
Responsible party
Sponsor
First posted
Jul 13, 2016
Start date
Jul 2016
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
May 21, 2024

Study contacts

Joshua Broder, MD
principal investigator · Duke University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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