Trial Outcomes & Findings for Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol (NCT NCT01592435)

Results Overview

1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.

Recruitment status

COMPLETED

Target enrollment

76 participants

Primary outcome timeframe

5 weeks after completion of data collection

Results posted on

2017-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Pred. & Invest.-All Study Participants Cedera AccuStitch Software is standard of care software currently used at sites. Carestream DR LLI software is investigational software used for reconstruction.
Overall Study STARTED	76
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pred. & Invest.-All Study Participants n=76 Participants Cedera AccuStitch Software is standard of care software currently used at sites. Carestream DR LLI software is investigational software used for reconstruction
Age, Categorical <=18 years	19 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks after completion of data collection

1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.

Outcome measures

Outcome measures
Measure	Predicate - Cedera AccuStitch Software n=76 Participants Cedera AccuStitch Software is standard of care software currently used at sites.
Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate)	3.01 units on a scale Standard Error 0.04

PRIMARY outcome

Timeframe: 5 weeks after completion of data collection

1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.

Outcome measures

Outcome measures
Measure	Predicate - Cedera AccuStitch Software n=76 Participants Cedera AccuStitch Software is standard of care software currently used at sites.
Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational)	3.16 units on a scale Standard Error 0.07

Adverse Events

Predicate - Cedera AccuStitch Software

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Invest. - Carestream DR LLI Software

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, MS, RN, RAC, Senior Manager, Clinical Affairs

Carestream Health, Inc.

Phone: 585-627-6557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place