Status:
COMPLETED
Clinical Evaluation for General Electric (GE) CT System
Lead Sponsor:
GE Healthcare
Conditions:
CT Scanners X Ray
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- • 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01909180
Start Date
May 1 2013
End Date
December 1 2013
Last Update
April 22 2016
Active Locations (1)
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1
Baptist South Florida Hospital
Miami, Florida, United States, 33143