Clinical Evaluation for General Electric (GE) CT System

NCT ID: NCT01909180

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

CT Scanners X Ray

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cardiac

Revolution CT Cardiac Imaging Scan

Group Type: EXPERIMENTAL

Revolution CT Scanner

Intervention Type: DEVICE

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

Body/Extremity

Revolution CT Body and/or Extremity Imaging Scan

Group Type: EXPERIMENTAL

Revolution CT Scanner

Intervention Type: DEVICE

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

Neuro

Revolution CT Brain and Spinal Cord Imaging Scan

Group Type: EXPERIMENTAL

Revolution CT Scanner

Intervention Type: DEVICE

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

Interventions

Revolution CT Scanner

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo Curry, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist South Hospital

Locations

Baptist South Florida Hospital

Miami, Florida, United States

Countries

United States

Other Identifiers

106-2011-GES-0003

Identifier Type: -

Identifier Source: org_study_id