Clinical trial NCT02445287: Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)
Official title: Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Carestream Health, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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 study undertaken will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 2D imaging functionality by comparing against the predicate CARESTREAM DRX-1 GOS detector used on adult cadaver specimens to capture the image pairs.

The study will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 3D imaging functionality by comparing against the reference PHILLIPS Multi Detector Computed Tomography (MDCT) scanner used on adult cadaver specimens (body part) to capture 3D volumetric exams using the anatomy of both upper and lower extremity specimens. The adult cadaver specimens will receive multiple x-ray exposures using the predicate devices for both 2D and 3D imaging. Target images from cadaver specimens will be reviewed by radiologist readers to rate diagnostic image quality, and the data will be included in a comparative evaluation.

The live human subject portion of the study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which will receive only one 3D volumetric exam using the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) scanner. Target images will be reviewed by radiologist readers to rate diagnostic image quality according to a radiologist reader scale applicable to 3D volumetric imaging.

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

Primary outcomes:
measure: Radlex Scale for Diagnostic Quality Ratings - 2D Images
timeFrame: 12 weeks after last image capture
measure: Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution
timeFrame: 12 weeks after last image capture
measure: Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK
timeFrame: 12 weeks after last image capture
measure: Radlex Scale for Diagnostic Quality Ratings - 3D Images SND
timeFrame: 12 weeks after last image capture
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UBMD Orthopaedics & Sports Medicine
name: John Marzo, MD
role: PRINCIPAL_INVESTIGATOR
References: