Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The predicate software is currently in place at the sites. Carestream will harvest that data and reconstruct with investigational software offsite. A comparison reader study will be performed upon completion of data collection. Please note this study is considered to be observational because there were no imaging of subject using investigational device. Subjects requiring standard of care diagnostic images were exposed using the commercially available Cedara system. The images captured on the Cedara system were then re-processed using the Carestream investigational software. Subjects gave informed consent for Carestream to reprocess their image data. They did not require any additional imaging using the investigational device.

Official Title
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Carestream Digital Radiography Long Length Imaging Manual Stitch Editor Software Data Collection

Conditions
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Spinal Injuries

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject has provided informed consent Male or Female who require Long Length Imaging Exclusion Criteria: Not able or willing to provide Informed Consent, or consent is withdrawn Not able to collect all required case information Patients who are unable to stand Images which are not clinically acceptable to the user Images without a reference object such as a ruler in the image.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pred. & Invest.-All Study Participants<br>Cedera AccuStitch Software is standard of care software currently used at sites. Carestream DR LLI software is investigational software used for reconstruction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate) | 1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes. | 5 weeks after completion of data collection | 
| Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational) | 1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes. | 5 weeks after completion of data collection |