Clinical Evaluation for General Electric (GE) CT System

Study Overview
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Brief Summary
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An external evaluation to obtain clinical data to create sample clinical images. The data will also be used for product and technology development, marketing materials, and inclusion in publications.

Detailed Description
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The image data were assessed using a Likert scale for image quality sufficient for diagnostic assessment.

Official Title
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Clinical Evaluation for GE CT System

Conditions
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CT Scanners X Ray

Intervention / Treatment
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* Device: Revolution CT Scanner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who voluntarily signed the Informed Consent Form (ICF). Male subjects 18 years of age or older. Female subjects 18 years of age or older. Females between 18 and 60 years of age must be non-lactating and non-pregnant as confirmed by negative urine pregnancy test., unless they had surgery resulting in sterilization or are post-menopausal according to the medical history. Exclusion Criteria: • Subjects previously enrolled in this Evaluation. Subjects who are not able or not willing to give written Informed Consent. For IV contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents or a history of multiple allergies or asthma. For IV contrast-enhanced CT exams, per the institution's guidelines on risk stratification and prophylaxis for Contrast Induced Neuropathy, subjects will be pre-screened via medical history review by qualified medical personnel for suspected renal function impairment and high risk subjects will undergo a serum creatinine lab test. Any subject with proven renal insufficiency will be excluded. Known pregnancy and nursing (lactating) females. Any subject with urgent medical condition requiring acute care. Any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject. Subjects who do not agree to allow GEHC personnel to be present during the scan.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac<br>Revolution CT Cardiac Imaging Scan | Device: Revolution CT Scanner<br>* These scans would be considered standard of care but, because the subjects are scanned on an uncleared device they are investigational.<br>|
| Experimental: Body/Extremity<br>Revolution CT Body and/or Extremity Imaging Scan | Device: Revolution CT Scanner<br>* These scans would be considered standard of care but, because the subjects are scanned on an uncleared device they are investigational.<br>|
| Experimental: Neuro<br>Revolution CT Brain and Spinal Cord Imaging Scan | Device: Revolution CT Scanner<br>* These scans would be considered standard of care but, because the subjects are scanned on an uncleared device they are investigational.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality | Image quality assessment on a 5 point Likert Scale: 5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information 1= Non-Diagnostic | 24 hours |