Clinical Image Evaluation for the DREX-KL80 Imaging System
Completed
- Conditions
- Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.
- Interventions
- Device: Radiography and Fluoroscopy Imaging System
- Registration Number
- NCT01318772
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fluoroscopy and Angiography Procedure Radiography and Fluoroscopy Imaging System Patient that have been scheduled for routine diagnostic fluoroscopy and angiography procedures by their physician.
- Primary Outcome Measures
Name Time Method Collection of representative images Estimated completion 4 weeks after start of the study Collect 30 to 60 represenative images to support pre-market submission.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SDMI
🇺🇸Las Vegas, Nevada, United States