Expired Study
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Las Vegas, Nevada 89109


Purpose:

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.


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


Study is Available At:


Original ID:

KH-001


NCT ID:

NCT01318772


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:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


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:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

42


Enrollment Type:

Actual


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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