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Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol (LLI-MSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carestream Health, Inc.
ClinicalTrials.gov Identifier:
NCT01592435
First received: May 3, 2012
Last updated: March 9, 2017
Last verified: March 2017
Results First Received: September 14, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Spinal Injuries

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Pred. & Invest.-All Study Participants
STARTED   76 
COMPLETED   76 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
76 subjects participated from both sites. 76 image sets were reconstructed with Cedara Accustitch software and the same 76 image sets were reconstructed with Carestream DR LLI software.

Reporting Groups
  Description
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


Baseline Measures
   Pred. & Invest.-All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 76 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      19  25.0% 
Between 18 and 65 years      57  75.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      44  57.9% 
Male      32  42.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate)   [ Time Frame: 5 weeks after completion of data collection ]

2.  Primary:   Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational)   [ Time Frame: 5 weeks after completion of data collection ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Susan Pate, MS, RN, RAC, Senior Manager, Clinical Affairs
Organization: Carestream Health, Inc.
phone: 585-627-6557
e-mail: susan.pate@carestream.com



Responsible Party: Carestream Health, Inc.
ClinicalTrials.gov Identifier: NCT01592435     History of Changes
Other Study ID Numbers: 8H9323
Study First Received: May 3, 2012
Results First Received: September 14, 2016
Last Updated: March 9, 2017