Clinical Evaluation for General Electric (GE) CT System

Clinical Evaluation for GE CT System

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.

Study Overview

• Status: Completed
• Conditions: CT Scanners X Ray
• Intervention / Treatment: Device: Revolution CT Scanner

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Baptist South Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Ricardo Curry, MD, Baptist South Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 106-2011-GES-0003