Clinical Evaluation for GE CT System

Computed Tomography Clinical Trial

Official title:

Clinical Evaluation for GE CT System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909180
• Other study ID #: 106-2011-GES-0003
• Status: Completed
• Phase: N/A
• First received: July 24, 2013
• Last updated: August 14, 2014
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Computed Tomography

Intervention

Device:
• Standard of care scan

• Investigational Scan

Locations

Country	Name	City	State
United States	Baptist South Florida Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image Quality		24 hours	No