Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)

NCT ID: NCT02445287

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-11-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Predicate & Invest.- Cadavers 2D & 3D

Radiation - Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).

Group Type: EXPERIMENTAL

Radiation

Intervention Type: RADIATION

Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only.

Investigational - Human Subjects 3D

Radiation - Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only.

Group Type: EXPERIMENTAL

Radiation

Intervention Type: RADIATION

Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only.

Interventions

Radiation

Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carestream Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Marzo, MD

Role: PRINCIPAL_INVESTIGATOR

UBMD Orthopaedics & Sports Medicine

Other Identifiers

6M3388

Identifier Type: -

Identifier Source: org_study_id