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Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors

NCT02383420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-04-15

Study results available
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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.

Conditions

  • Healthy

Interventions

RADIATION

Radiation

Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.

Sponsors & Collaborators

  • Carestream Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Hobbs, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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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 NCT02383420 on ClinicalTrials.gov