Clinical Evaluation for General Electric (GE) CT System

General Electric (GE)

Status: Completed

Conditions: CT Scanners X Ray

Treatments: Device: Revolution CT Scanner

Study type: Interventional

Funder types: Industry

Identifiers

NCT01909180

106-2011-GES-0003

Details and patient eligibility

About

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.

Full description

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

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 3 patient groups

Cardiac

Experimental group

Description:

Revolution CT Cardiac Imaging Scan

Treatment:

Device: Revolution CT Scanner

Body/Extremity

Experimental group

Description:

Revolution CT Body and/or Extremity Imaging Scan

Treatment:

Device: Revolution CT Scanner

Neuro

Experimental group

Description:

Revolution CT Brain and Spinal Cord Imaging Scan

Treatment:

Device: Revolution CT Scanner