Spinal Injuries
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Carestream Health, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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* Not able or willing to provide Informed Consent, or consent is withdrawn * Not able to collect all required case information * Patients who are unable to stand * Images which are not clinically acceptable to the user * Images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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate) | 5 weeks after completion of data collection | 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. |
| Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational) | 5 weeks after completion of data collection | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pred. & Invest.-All Study Participants Cedera AccuStitch Software is standard of care software currently used at sites.
Carestream DR LLI software is investigational software used for reconstruction | 76 |
| Total | 76 |
Baseline characteristics
| Characteristic | Pred. & Invest.-All Study Participants |
|---|---|
| Age, Categorical <=18 years | 19 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 76 | 0 / 76 |
| serious Total, serious adverse events | 0 / 76 | 0 / 76 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate - Cedera AccuStitch Software | Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational) | 3.16 units on a scale | Standard Error 0.07 |
p-value: 0t-test, 1 sided
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate - Cedera AccuStitch Software | Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate) | 3.01 units on a scale | Standard Error 0.04 |
p-value: 0.02t-test, 1 sided