Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Evaluation for General Electric (GE) CT System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01909180
Recruitment Status : Completed
First Posted : July 26, 2013
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
CT Scanners X Ray Device: Revolution CT Scanner Not Applicable

Detailed Description:
The image data were assessed using a Likert scale for image quality sufficient for diagnostic assessment.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation for GE CT System
Study Start Date : May 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Image Quality [ Time Frame: 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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909180


Locations
Layout table for location information
United States, Florida
Baptist South Florida Hospital
Miami, Florida, United States, 33143
Sponsors and Collaborators
GE Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Ricardo Curry, MD Baptist South Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01909180    
Other Study ID Numbers: 106-2011-GES-0003
First Posted: July 26, 2013    Key Record Dates
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: March 2016