An observational study in Spinal Injuries, sponsored by Carestream Health, Inc.. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2017-04-06.
Sponsored by Carestream Health, Inc. · Observational
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.
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.
83 studies on the registry are indexed under Spinal Injuries; 18 are open to participants now.
This study's enrollment of 76 is above the median of 69 across 29 observational studies indexed under Spinal Injuries.
Browse Spinal Injuries studies →Carestream Health, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Cedera AccuStitch Software is standard of care software currently used at sites. Carestream DR LLI software is investigational software used for reconstruction.
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.
Time frame: 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.
Time frame: 5 weeks after completion of data collection
| Milestone | Pred. & Invest.-All Study Participants |
|---|---|
| Started | 76 |
| Completed | 76 |
| Not completed | 0 |
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.
| units on a scale | Predicate - Cedera AccuStitch Software |
|---|---|
| Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate) | 3.01 ± 0.04 |
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.
| units on a scale | Invest. - Carestream DR LLI Software |
|---|---|
| Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational) | 3.16 ± 0.07 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Predicate - Cedera AccuStitch Software | — | 0/76 (0%) | 0/76 (0%) |
| Invest. - Carestream DR LLI Software | — | 0/76 (0%) | 0/76 (0%) |
76 subjects participated from both sites. 76 image sets were reconstructed with Cedara Accustitch software and the same 76 image sets were reconstructed with Carestream DR LLI software.
| Age, Categorical(Participants) | Pred. & Invest.-All Study Participants |
|---|---|
| <=18 years | 19 |
| Between 18 and 65 years | 57 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Pred. & Invest.-All Study Participants |
|---|---|
| Female | 44 |
| Male | 32 |
Plan to share: No
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Carestream Health, Inc.