Clinical trial NCT02337959: Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors
Official title: Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Carestream Health, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radlex Scale for Diagnostic Capability Ratings
timeFrame: 9 weeks after last x-ray capture
Secondary outcomes:
measure: Pair Preference Rating
timeFrame: 9 weeks after last x-ray capture
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Susan Hobbs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis Children's Hospital
name: Steven Don, MD
role: PRINCIPAL_INVESTIGATOR
References: