Trial Outcomes & Findings for Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors (NCT NCT02383420)
NCT ID: NCT02383420
Last Updated: 2016-04-15
Results Overview
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.
COMPLETED
NA
23 participants
9 weeks after last x-ray capture
2016-04-15
Participant Flow
Participant milestones
| Measure |
Predicate & Invest.-GOS
Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
|
Predicate & Invest.-CsI
Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
|
Predicate & Investigational-Cadavers
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 both the GoS and the CsI investigational detector.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
3
|
|
Overall Study
COMPLETED
|
8
|
10
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors
Baseline characteristics by cohort
| Measure |
Predicate & Invest.-GOS
n=8 Participants
Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
|
Predicate & Invest.-CsI
n=10 Participants
Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
|
Predicate & Invest.-Cadavers GOS & CsI
n=3 Participants
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 both the GoS and the CsI investigational detector.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
21 years and older
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
3 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
3 participants
n=5 Participants
|
21 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 9 weeks after last x-ray capturePopulation: A total of 177 image pairs were included for the reader study. Of the 177 pairs, 160 were cadaver image pairs. A total of seventeen (17) adult live human subject pairs were included in the reader study.
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.
Outcome measures
| Measure |
Predicate
n=177 images
DRX-1 Detector, Live Subjects and Cadavers
|
Investigational
n=177 images
DRX PRO 3543/C (GOS \& CsI) Detectors, Live Subjects \& Cadavers
|
|---|---|---|
|
Radlex Scale for Diagnostic Capability Ratings
|
3.0610 units on a scale
Standard Error 0.0140
|
3.0633 units on a scale
Standard Error 0.0141
|
SECONDARY outcome
Timeframe: 9 weeks after last x-ray capturePopulation: cadavers and live human subjects
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.
Outcome measures
| Measure |
Predicate
n=177 units
DRX-1 Detector, Live Subjects and Cadavers
|
Investigational
DRX PRO 3543/C (GOS \& CsI) Detectors, Live Subjects \& Cadavers
|
|---|---|---|
|
Pair Preference Rating Scale
|
0.1333 units on a scale
Standard Error 0.0209
|
—
|
Adverse Events
Predicate & Invest.-GOS
Predicate & Invest.-CsI
Predicate & Invest.-Cadavers GOS & CsI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susan Pate, Senior Clinical Affairs Manager
Carestream Health, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place