NCT01318772CompletedNot Applicable
Clinical Image Evaluation for the KALARE (DREX-KL80) With New Digital Camera and Image Processor
Toshiba America Medical Systems, Inc.1 site in 1 country42 target enrollmentStarted: December 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Collection of representative images
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Collection of representative images
Time Frame: Estimated completion 4 weeks after start of the study
Collect 30 to 60 represenative images to support pre-market submission.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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