Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | March 2015 |
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.
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.
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.
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.
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
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