N/A
N=23
Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02383420 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Radlex Scale for Diagnostic Capability Ratings — 3.0610; 3.0633 units on a scale — p=0.415
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation (Radiation)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Carestream Health, Inc.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radlex Scale for Diagnostic Capability Ratings |
3.0610; 3.0633 | 0.415 |
| SECONDARY Pair Preference Rating Scale |
0.1333 | 0.0000 sig |
Summary
The purpose of this clinical study is to evaluate the imaging performance of the Carestream PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the "investigational devices") as compared to the currently marketed Carestream DRX-1 Detector (referred to as the "predicate device"). Both detectors are flat panel digital imaging devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors in the US. The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.
Eligibility Criteria
Inclusion Criteria
- X-ray images of nearly identical positioning and exposure
- No visible image artifacts
- Subject 21 years or older
- Subject has provided informed consent
- Subject is in good general health (is able to be still to reduce the potential of motion in the images)
- Subject is able to stand for two (2) x-rays
Exclusion Criteria
- Images that are not clinically acceptable for clinical radiographic reading as determined by the Principal Investigator.
- Subject is pregnant or suspicious of being pregnant
- Subject not able or willing to provide Informed Consent, or consent is withdrawn
- Not able to collect all required case information
- Subject has a history of high radiation exposure:
- Subject has undergone radiation therapy
- Subject has had two (2) or more CT scans within the past year
Data sourced from ClinicalTrials.gov (NCT02383420). 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.