Clinical Image Evaluation for the DREX-KL80 Imaging System
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|ClinicalTrials.gov Identifier: NCT01318772|
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : March 18, 2011
|Condition or disease||Intervention/treatment|
|Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.||Device: Radiography and Fluoroscopy Imaging System|
|Study Type :||Observational|
|Actual Enrollment :||42 participants|
|Official Title:||Clinical Image Evaluation for the KALARE (DREX-KL80) With New Digital Camera and Image Processor|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Fluoroscopy and Angiography Procedure
Patient that have been scheduled for routine diagnostic fluoroscopy and angiography procedures by their physician.
Device: Radiography and Fluoroscopy Imaging System
KALARE (DREX-KL80) is a new high resolution digital system designed for digital spot imaging, with the primary goal to address R/F and DSA clinical applications and produce images in a digital format.
The system includes a new digital camera and a new image processor.
Other Name: KALARE (DREX-KL80)
- Collection of representative images [ Time Frame: Estimated completion 4 weeks after start of the study ]Collect 30 to 60 represenative images to support pre-market submission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318772
|United States, Nevada|
|Las Vegas, Nevada, United States, 89109|
|Principal Investigator:||Mark Winkler, M.D.||Stienberg Diagnostic Meidcal Imaging (SDMI)|