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

  • STATUS
    Recruiting
  • End date
    Feb 26, 2025
  • participants needed
    300
  • sponsor
    Duke University
Updated on 26 January 2021
ct scan
safety issues
ultrasound examination
imaging techniques
surgical reconstruction
pelvic ultrasound
3d ultrasound

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.

Details
Condition Diverticulitis, Gastroenteritis, Intestinal Diseases, Pancreatitis, OVARIAN CYST, Ovarian disorder, Abdominal Injury, Gallstones, Nephropathy, Cancer, Trauma, Pancreatic disorder, Vascular Diseases, Polyp, Cholelithiasis, Cyst, GASTROINTESTINAL DISORDER, Aortic Aneurysm, UTERINE FIBROID, Digestive System Disease, Ectopic Pregnancy, Cholecystolithiasis, Nephrolithiasis, Pregnancy, Appendicitis, Aneurysm, KIDNEY STONE, Pancreatic Disorders, Intra-Abdominal Infections, Kidney Disease (Pediatric), Cancer/Tumors, Gastrointestinal Diseases and Disorders, Ovarian Function, Ewing's Family Tumors, Acute Appendicitis, Evidence of Cholecystectomy, Intrauterine Pregnancy, Intraabdominal Infections, Uterine Abnominalies, Bladder Abnominalies, Testicular Abnominalies, Abdominal Infection, Cancer (Pediatric), Uterine Fibroids, Leiomyomas, Kidney Stones, Wounds, Ovarian Cysts, Kidney Disease, Neoplasms, Bowel Dysfunction, Polyps, Abdominal Trauma, Intra-abdominal Infection, vascular disorder, extra-uterine pregnancy, gastrointestinal diseases, gastrointestinal disorders, gastrointestinal disease, renal stones, abdominal injuries, vascular disease, vasculopathy, vasc, digestive disorders, digestive diseases, digestive disorder, digestive disease, bowel disorders, enteropathy, bowel disease, intestinal disease, diseases of the intestinal tract, gallbladder stones, aorta aneurysm, renal lithiasis
Clinical Study IdentifierNCT02831556
SponsorDuke University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Pregnancy or Intrauterine Pregnancy or Vascular Diseases or Cholelithiasis or KIDNEY STONE or Cyst or Ectopic Pregnancy or Uterine Fibroids or Testicu...?
Do you have any of these conditions: Uterine Fibroids or Pancreatitis or digestive disorder or Pancreatic disorder or Gastrointestinal Diseases and Disorders or gastrointestinal disorders...?
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
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