Computed Tomography
Conditions
Brief summary
The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting.
Detailed description
Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise to evaluate the product. This data and analysis will help support regulatory submission.
Interventions
DEVICEInvestigational CT Scan
All pre-contrast testing and administration of supporting medications shall be done according to the hospital's SOC. Images will then be compared with the previously acquired imaging conducted as standard of care. The investigational scan takes between 10-30 minutes.
Sponsors
GE Healthcare
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects may be included in this study if they meet the following criteria: 1. Who are 18 year of age or older; 2. Able to sign and date the informed consent form; AND 3. Who have in the past 120 days or will in the future 30 days from the day of consent undergo a clinically indicated imaging exam (MRI, CT, radiograph, nuclear medicine, ultrasound, bone material density, interventional radiology procedure) of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior exam.
Exclusion criteria
Subjects may be excluded from participating in study if they meet any of the following criteria: 1. Who are pregnant or lactating; 2. Who were previously enrolled in this study; 3. For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents; 4. For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel; 5. Who are in need of urgent or emergent care; 6. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; and, 7. Who are unwilling to have GEHC personnel present for the CT exam.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data Collection | 12 months | Number of investigational CT scans along with standard of care CT images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Information | 12 months | Type and numbers of AEs, SAEs, and Device Deficiencies |
| Assessment of Image Quality | 12 months | Images created from the raw investigational CT scan data will be scored for image quality |
Countries
United States
Contacts
STUDY_DIRECTORMICT Global Research Manager
GE Healthcare
Outcome results
None listed