Clinical Image Evaluation for the DREX-KL80 Imaging System

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

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.

Study Overview

• Status: Completed
• Conditions: Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.
• Intervention / Treatment: Device: Radiography and Fluoroscopy Imaging System

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • SDMI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patient 18 years and older

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: KALARE (DREX-KL80)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Toshiba America Medical Systems, Inc.
• Investigators: Principal Investigator: Mark Winkler, M.D., Stienberg Diagnostic Meidcal Imaging (SDMI)

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 17, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (Estimate): March 18, 2011

Study Record Updates

• Last Update Posted (Estimate): March 18, 2011
• Last Update Submitted That Met QC Criteria: March 17, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: KH-001