N/A
N=76
Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol
Spinal Injuries
Bottom Line
View on ClinicalTrials.gov: NCT01592435 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate) — 3.01 units on a scale — p=0.02
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Carestream Health, Inc.
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate) |
3.01 | 0.02 sig |
| PRIMARY Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational) |
3.16 | 0.00 sig |
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.
Eligibility Criteria
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- Not able or willing to provide Informed Consent, or consent is withdrawn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.
Data sourced from ClinicalTrials.gov (NCT01592435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.