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Clinical Image Evaluation for the DREX-KL80 Imaging System

NCT01318772 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2011-03-18

No results posted yet for this study

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.

Conditions

  • Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.

Interventions

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.

Sponsors & Collaborators

  • Toshiba America Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Winkler, M.D. · Stienberg Diagnostic Meidcal Imaging (SDMI)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01318772 on ClinicalTrials.gov