CT Scanners X Ray
Conditions
Brief summary
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
The image data were assessed using a Likert scale for image quality sufficient for diagnostic assessment.
Interventions
DEVICERevolution CT Scanner
These scans would be considered standard of care but, because the subjects are scanned on an uncleared device they are investigational.
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality | 24 hours | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Scan This is a single arm clinical trial.
Standard of care scan
Investigational Scan | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | Standard of Care Scan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
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
Time frame: 24 hours
Population: All cases were sufficient and had acceptable, good or excellent image quality
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiac | Image Quality | 4.53 units on a scale | Standard Deviation 0.68 |
| Body/ Extremity | Image Quality | 4.44 units on a scale | Standard Deviation 0.67 |
| Neuro | Image Quality | 4.63 units on a scale | Standard Deviation 0.61 |