Expired Study
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Las Vegas, Nevada 89109


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.


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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Clinical Image Evaluation for the DREX-KL80 Imaging System

Official Title:

Clinical Image Evaluation for the KALARE (DREX-KL80) With New Digital Camera and Image Processor

Overall Status:


Study Phase:




Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Toshiba America Medical Systems, Inc.

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Observational Model: Case-Only, Time Perspective:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Mark Winkler, M.D.
Principal Investigator
Stienberg Diagnostic Meidcal Imaging (SDMI)

Study Dates

Start Date:December 2010
Completion Date:January 2011
Completion Type:Actual
Primary Completion Date:January 2011
Primary Completion Type:Actual
Verification Date:March 2011
Last Changed Date:March 17, 2011
First Received Date:March 17, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Collection of representative images
Time Frame:Estimated completion 4 weeks after start of the study
Safety Issues:False
Description:Collect 30 to 60 represenative images to support pre-market submission.

Study Interventions

Intervention Type:Device
Name:Radiography and Fluoroscopy Imaging System
Description: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.
Arm Name:Fluoroscopy and Angiography Procedure
Other Name:KALARE (DREX-KL80)

Study Arms

Study Arm Type:Other
Arm Name:Fluoroscopy and Angiography Procedure
Description:Patient that have been scheduled for routine diagnostic fluoroscopy and angiography procedures by their physician.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Toshiba America Medical Systems, Inc.

Samples and Retentions

Study Population: Male and female patient 18 years and older
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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