Trial Outcomes & Findings for Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors (NCT NCT02337959)

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

9 weeks after last x-ray capture

Results posted on

2016-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Predicate & Investigational - GOS Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.	Predicate & Investigational - CsI Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.	Predicate & Investigational - Cadavers GOS & CsI 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 the both the GoS and the CsI investigational detector.
Overall Study STARTED	10	10	7
Overall Study COMPLETED	10	7	7
Overall Study NOT COMPLETED	0	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Predicate & Investigational - GOS n=10 Participants Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.	Predicate & Investigational - CsI n=7 Participants Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.	Predicate & Investigational-Cadavers GOS & CsI n=7 Participants 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 the both the GoS and the CsI investigational detector.	Total n=24 Participants Total of all reporting groups
Age, Customized 21 years and older	10 participants n=5 Participants	7 participants n=7 Participants	4 participants n=5 Participants	21 participants n=4 Participants
Age, Customized < 21 years	0 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants
Sex/Gender, Customized Unknown	10 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants	24 participants n=4 Participants

PRIMARY outcome

Timeframe: 9 weeks after last x-ray capture

Population: A total of 139 image pairs were included for the reader study. Of the 139 pairs, 122 were cadaver image pairs. Fifty-two (52) of the cadaver image pairs were from pediatric cadavers and seventy (70) pairs were from adult cadavers. 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

Outcome measures
Measure	Predicate n=139 images DRX-1 Detector, Cadavers \& Live Subjects	Investigational n=139 images DRX Plus 3543/C (GOS \& CsI) Detectors, Cadavers \& Live Subjects
Radlex Scale for Diagnostic Capability Ratings	3.0388 units on a scale Standard Error 0.0163	3.0547 units on a scale Standard Error 0.0170

SECONDARY outcome

Timeframe: 9 weeks after last x-ray capture

Population: 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

Outcome measures
Measure	Predicate n=139 images DRX-1 Detector, Cadavers \& Live Subjects	Investigational DRX Plus 3543/C (GOS \& CsI) Detectors, Cadavers \& Live Subjects
Pair Preference Rating	0.2446 units on a scale Standard Error 0.0291	—

Adverse Events

Predicate & Invest.-GOS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Predicate & Invest.-CsI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Predicate & Invest.-Cadavers GOS & CsI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan Pate, RN, MS, RAC

Carestream Health, Inc.

Phone: 585-627-6557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place