Clinical Evaluation for GE CT System



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:May 2013
Contact:Mikhail Chkolnik, MD
Email:mikhail.chkolnik@ge.com
Phone:262-548-2799

Use our guide to learn which trials are right for you!

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.


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.
We found this trial at
1
site
?
mi
from
Miami, FL
Click here to add this to my saved trials