Trial Outcomes & Findings for Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT) (NCT NCT02445287)
NCT ID: NCT02445287
Last Updated: 2017-01-30
Results Overview
1-1.9-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. 2-2.9-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. 3-3.9-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
48 participants
12 weeks after last image capture
2017-01-30
Participant Flow
Participant milestones
| Measure |
Predicate & Invest.- Cadavers 2D & 3D
Cadaveric specimens will be imaged with 2D devices CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).
|
Investigational - Human Subjects 3D
Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only.
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|---|---|---|
|
Overall Study
STARTED
|
35
|
13
|
|
Overall Study
COMPLETED
|
35
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)
Baseline characteristics by cohort
| Measure |
Predicate & Invest.- Cadavers 2D & 3D
n=35 Participants
Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph. Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
|
Investigational - Human Subjects 3D
n=13 Participants
Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
|
Total
n=48 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
18 years or older
|
35 participants
n=5 Participants
|
13 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Unknown (not collected)
|
35 participants
n=5 Participants
|
13 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after last image capturePopulation: 140 total image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for each of the above two arms.
1-1.9-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. 2-2.9-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. 3-3.9-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 - Cadavers 2D
n=140 images
The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis \& Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.
|
Investigational - Cadavers 2D
n=140 images
The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis \& Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.
|
|---|---|---|
|
Radlex Scale for Diagnostic Quality Ratings - 2D Images
|
3.4093 units on a scale
Standard Error 0.0601
|
3.4179 units on a scale
Standard Error 0.0602
|
PRIMARY outcome
Timeframe: 12 weeks after last image capturePopulation: 140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers \& Human Subjects 3D-High Resolution arm above.
1-1.9-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. 2-2.9-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. 3-3.9-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 - Cadavers 2D
n=140 images
The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis \& Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.
|
Investigational - Cadavers 2D
n=204 images
The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis \& Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.
|
|---|---|---|
|
Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution
|
3.5457 units on a scale
Standard Error 0.0316
|
3.8377 units on a scale
Standard Error 0.0211
|
PRIMARY outcome
Timeframe: 12 weeks after last image capturePopulation: 140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers \& Human Subjects 3D-FDK arm above.
1-1.9-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. 2-2.9-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. 3-3.9-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 - Cadavers 2D
n=140 images
The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis \& Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.
|
Investigational - Cadavers 2D
n=204 images
The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis \& Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.
|
|---|---|---|
|
Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK
|
3.5277 units on a scale
Standard Error 0.0316
|
3.5353 units on a scale
Standard Error 0.0372
|
PRIMARY outcome
Timeframe: 12 weeks after last image capturePopulation: 140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers \& Human Subjects 3D-SND arm above.
1-1.9-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. 2-2.9-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. 3-3.9-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 - Cadavers 2D
n=140 images
The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis \& Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.
|
Investigational - Cadavers 2D
n=204 images
The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis \& Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.
|
|---|---|---|
|
Radlex Scale for Diagnostic Quality Ratings - 3D Images SND
|
3.5277 units on a scale
Standard Error 0.0316
|
3.6319 units on a scale
Standard Error 0.0333
|
Adverse Events
Predicate & Invest.- Cadavers 2D
Reference & Invest. - Cadavers 3D
Investigational - Human Subjects 3D
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place