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OpenTrials
Completed

NCT Number: NCT01909180

Clinical Evaluation for General Electric (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.

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist South Florida Hospital

Miami, Florida, 33143, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Revolution CT Scanner

Device

These scans would be considered "standard of care" but, because the subjects are scanned on an uncleared device they are investigational.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

Clinical Evaluation for GE CT System

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2013
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.