Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors

The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the currently marketed Carestream DRX-1 Detector. 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Radiation: Radiation

Detailed Description

The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) ("investigational device") as compared to the currently marketed Carestream DRX-1 Detector ("predicate device"). The evaluation will consist primarily of comparing the diagnostic image quality of double-imaged pediatric and adult cadaver studies and adult live human subject studies acquired under the same exposure technique for similar detector types (i.e. comparing DRX-1 GOS predicate with DRX Plus GOS) or exposure adjusted technique when different detector types are compared.

Under the same position and radiological technique, pediatric and adult cadaver studies, and adult live human subject studies, using double-exposed images will be acquired to evaluate the diagnostic image quality of the investigational device versus the predicate device. Target images will be assembled and reviewed in a side-by-side Comparative Evaluation to statistically confirm the findings of this evaluation.

The live human subject portion of this study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which they will have two (2) x-rays taken. The first x-ray will follow standard technique using the cleared predicate detector currently in use at the site. Following the first x-ray, we will take one additional x-ray of the same part of the body with one (1) of the investigational detectors. The x-ray from the investigational detector will not be used to diagnose.

If the x-ray obtained by the standard DR x-ray detector shows any unforeseen, unusual or abnormal findings, these findings will be communicated to the subject and their doctor by USPS mail.

Reason for Observational Study Type: There are three (3) physical detectors being used in this study. Each detector is 35 centimeters by 43 centimeters. None of the subjects will given a detector.

All subjects are healthy volunteers recruited by flyer. All subjects will be imaged with the same predicate detector and one (1) of the investigational detectors.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642-8648
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• X-ray images of nearly identical positioning and exposure
• No visible image artifacts
• Subject 21years or older
• Subject has provided informed consent
• Subject is in good general health
• Subject is able to stand for two (2) x-rays

Exclusion Criteria:

• Images that are not clinically acceptable for clinical radiographic reading as determined by the Principal Investigator.
• Subject is pregnant or suspicious of being 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
• Has had two (2) or more CT scans within the past year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Predicate & Invest.-GOS; Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.	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 detectors.
Experimental: Predicate & Invest.-CsI; Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.	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 detectors.
Experimental: Predicate & Invest.-Cadavers GOS & CsI; Radiation - 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 the both the GoS and the CsI investigational detectors.	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 detectors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radlex Scale for Diagnostic Capability Ratings	1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.	9 weeks after last x-ray capture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pair Preference Rating	During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.	9 weeks after last x-ray capture

Collaborators and Investigators

• Sponsor: Carestream Health, Inc.
• Investigators: Principal Investigator: Susan Hobbs, MD, University of Rochester; Principal Investigator: Steven Don, MD, St. Louis Children's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 2, 2015
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Estimate): April 18, 2016
• Last Update Submitted That Met QC Criteria: April 15, 2016
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Other Study ID Numbers: 6K9740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO