MedTrace Logo

Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)

NCT02445287 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-01-30

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy

Interventions

RADIATION

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.

Sponsors & Collaborators

  • Carestream Health, Inc.

    lead INDUSTRY

Principal Investigators

  • John Marzo, MD · UBMD Orthopaedics & Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-11-30
Completion
2015-11-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02445287 on ClinicalTrials.gov