N/A
N=48
Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02445287 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Radlex Scale for Diagnostic Quality Ratings - 2D Images — 3.4093; 3.4179 units on a scale — p=0.920
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Carestream Health, Inc.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - 2D Images |
3.4093; 3.4179 | 0.920 |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution |
3.5457; 3.8377 | 0.000 sig |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK |
3.5277; 3.5353 | 0.000 sig |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - 3D Images SND |
3.5277; 3.6319 | 0.012 sig |
Summary
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new CARESTREAM Cone Beam Computed Tomography (CBCT) scanner 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
- Subject 18 years or older
- Subject has provided informed consent
- Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion in the images.
- Subject(s) may have a metal screw, plate or artificial joint
Exclusion Criteria
- Subject is pregnant
- Not able or willing to provide Informed Consent, or consent is withdrawn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:
- Has undergone radiation therapy
Data sourced from ClinicalTrials.gov (NCT02445287). 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.