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Clinical Image Evaluation for the DREX-KL80 Imaging System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318772
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : March 18, 2011
Sponsor:
Information provided by:
Toshiba America Medical Systems, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation. Device: Radiography and Fluoroscopy Imaging System

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

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Group/Cohort Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male and female patient 18 years and older
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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United States, Nevada
SDMI
Las Vegas, Nevada, United States, 89109
Sponsors and Collaborators
Toshiba America Medical Systems, Inc.
Investigators
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Principal Investigator: Mark Winkler, M.D. Stienberg Diagnostic Meidcal Imaging (SDMI)
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Responsible Party: Charlemagne Chua, Manager, Regulatory Affairs, Toshiba America Medical Systems
ClinicalTrials.gov Identifier: NCT01318772    
Other Study ID Numbers: KH-001
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: March 18, 2011
Last Verified: March 2011