Clinical trial · Observational
Point of Care 3D Ultrasound for Various Applications: A Pilot Study
A Pilot Study to Test Rapid Acquisition of Point of Care Ultrasound for Various Applications
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (23)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Injuries | — | UNRESOLVED | — |
| Aortic Aneurysm | — | UNRESOLVED | — |
| Appendicitis | — | UNRESOLVED | — |
| Bladder Abnominalies | — | UNRESOLVED | — |
| Digestive System Diseases | — | UNRESOLVED | — |
| Diverticulitis | — | UNRESOLVED | — |
| Evidence of Cholecystectomy | — | UNRESOLVED | — |
| Gallstones | — | UNRESOLVED | — |
| Gastrointestinal Diseases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Emergency Department Subjects
- description
- Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.
- label
- Non-patient volunteers
- description
- Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.
Primary outcomes (1)
- measure
- Experimental ultrasound diagnosis agreement with final reference standard diagnosis
- timeFrame
- 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)
- measure
- Duration of experimental ultrasound exam
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available