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NCT02507674 · ClinicalTrials.gov registry record
Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 19
- Enrollment target
NCT02507674 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 19 participants.
The verdict
NCT02507674 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 19 participants
- Enrollment target
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 for pediatric appendicitis. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen. 2. Study activities and population group. The study population will be a convenience sample of patients 18 years and younger with suspected appendicitis, whose clinical care (unrelated to the study) includes ultrasound and/or CT of the abdomen. 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. If not evident from the patient medical record, the final diagnosis will be confirmed by a telephone call to the subject 2 weeks after the initial visit. 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 to determine the frequency of visualization of the appendix and whether the appendix was deemed normal or abnormal. 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. We are not measuring the effect of the ultrasound examination on the subjects' outcomes.
Interventions
- DEVICE ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-07-16 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02507674
The ClinicalTrials.gov registry entry for NCT02507674 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ultrasound is the first listed.
NCT02507674 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02507674 about?
NCT02507674 is a clinical study titled "Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study". 1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound for pediatric appendicitis. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen...
What is the current status of trial NCT02507674?
This trial is currently completed. The enrollment target is 19 participants. The study started on 2015-10. Estimated completion is 2016-07-16.
What interventions are being tested in trial NCT02507674?
The interventions under investigation include: ultrasound (DEVICE).
Who is sponsoring clinical trial NCT02507674?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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