- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02831556
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
Summary
- 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.
- 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.
Study Overview
Status
Conditions
- Digestive System Diseases
- Gastrointestinal Diseases
- Ovarian Cysts
- Intestinal Diseases
- Intraabdominal Infections
- Pregnancy
- Polyps
- Appendicitis
- Diverticulitis
- Pancreatitis
- Gallstones
- Aortic Aneurysm
- Abdominal Injuries
- Pregnancy, Ectopic
- Uterine Fibroids
- Kidney Stones
- Tumors
- Vascular Disease
- Evidence of Cholecystectomy
- Intrauterine Pregnancy
- Uterine Abnominalies
- Bladder Abnominalies
- Testicular Abnominalies
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Joshua Broder, MD
- Email: joshua.broder@duke.edu
Study Contact Backup
- Name: Elias Jaffa, MD
- Email: elias.jaffa@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Recruiting
- Duke University Medical Center
-
Contact:
- Joshua S Broder, MD
- Phone Number: 919-681-2247
- Email: joshua.broder@duke.edu
-
Principal Investigator:
- Joshua S Broder, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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.
|
4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joshua Broder, MD, Duke University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Infections
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Kidney Diseases
- Urologic Diseases
- Wounds and Injuries
- Endocrine System Diseases
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastroenteritis
- Pathological Conditions, Anatomical
- Pregnancy Complications
- Gallbladder Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Cecal Diseases
- Diverticular Diseases
- Neoplasms, Muscle Tissue
- Aneurysm
- Urolithiasis
- Urinary Calculi
- Calculi
- Cholelithiasis
- Cholecystolithiasis
- Aortic Diseases
- Nephrolithiasis
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Vascular Diseases
- Intraabdominal Infections
- Gastrointestinal Diseases
- Digestive System Diseases
- Intestinal Diseases
- Appendicitis
- Diverticulitis
- Pancreatitis
- Kidney Calculi
- Gallstones
- Leiomyoma
- Aortic Aneurysm
- Pregnancy, Ectopic
- Ovarian Cysts
- Abdominal Injuries
Other Study ID Numbers
- Pro00071789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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