Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | April 2015 |
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.
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.
The purpose of this clinical study is to evaluate the imaging performance of the
investigational devices as compared to the currently marketed predicate device. The
evaluation will consist primarily of comparing the diagnostic image quality of pediatric and
adult cadaver studies and adult live human subject studies acquired under the same exposure
technique.
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.
investigational devices as compared to the currently marketed predicate device. The
evaluation will consist primarily of comparing the diagnostic image quality of pediatric and
adult cadaver studies and adult live human subject studies acquired under the same exposure
technique.
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 21 years or older
- Subject has provided informed consent
- Subject is in good general health (is able to be still to reduce the potential of
motion in the images)
- 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
- Subject 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:
- Subject has undergone radiation therapy
- Subject has had two (2) or more CT scans within the past year
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