Clinical Image Evaluation for the DREX-KL80 Imaging System

Completed

Conditions studied: Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.

In brief

The purpose of this study is to acquire the clinical data required by the United States Food and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution imaging system for fluoroscopy/radiography. It is expected that the new KALARE (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of 30 cases will be submitted for evaluation of claims for intended clinical applications.

Key facts

Study ID

NCT01318772

Run by

Toshiba America Medical Systems, Inc.

People needed

42

Starts

2010-12-01

Expected to finish

2011-01-01

Last updated by the study team

2011-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female patient 18 years and older
• Not pregnant
• Not a safety risk patient

You may not qualify if…

• Male and female patient under 18 years old
• Pregnant subjects
• High safety risk subjects
• Subjects and/or Legal Guardian Unable to provide informed consent

Where it is running

• SDMI — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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