Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol (LLI-MSE)
The study objective is to acquire composite images generated by the Carestream Long Length Imaging (LLI) software and demonstrate that the images stitched using the Carestream LLI software and the images stitched using a approved predicate device are acceptable for clinical use.
Long Length Imaging
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Carestream Digital Radiography Long Length Imaging Manual Stitch Editor Software Data Collection|
- Demonstrate Acceptability for Clinical Use [ Time Frame: End of Study ] [ Designated as safety issue: No ]Demonstrate that the images stitched using the Carestream LLI software and the images stitched using a cleared predicate device are acceptable for clinical use
|Study Start Date:||April 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
The study consists of subject enrollment to collect images in a clinical setting, followed by a review of the stitched images by radiologists or qualified orthopedic surgeons to assess overall usability of the composite images.
This study includes clinical data collection of individual (raw and processed) and composite DR images from a Carestream device using alpha rotation to acquire the images. There is no subject involvement other than obtaining informed consent in order to use patient images and Case Record Forms (CRF), including supporting radiology reports. This study has no effect on clinical treatment and no foreseen risks to enrolled subjects.
|United States, Illinois|
|Memorial Medical Center|
|Springfield, Illinois, United States, 62781|
|United States, Missouri|
|Heartland Regional Medical Center|
|St. Joseph, Missouri, United States, 64507|