Clinical Evaluation for General Electric (GE) CT System

Not Applicable

Completed

• Conditions: CT Scanners X Ray
• Interventions: Device: Revolution CT Scanner

• Registration Number: NCT01909180
• Lead Sponsor: GE Healthcare

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Results First Submitted: 2015-03-12
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-22
• Last Update Submitted: 2016-03-22
• Results First Posted: 2016-04-22
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac	Revolution CT Scanner	Revolution CT Cardiac Imaging Scan
Body/Extremity	Revolution CT Scanner	Revolution CT Body and/or Extremity Imaging Scan
Neuro	Revolution CT Scanner	Revolution CT Brain and Spinal Cord Imaging Scan

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Baptist South Florida Hospital; 🇺🇸 Miami, Florida, United States