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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592435
First Posted: May 7, 2012
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carestream Health, Inc.
  Purpose
The study objective is to acquire composite images generated by the Carestream Long Length Imaging (LLI) software and demonstrate that the images stitched using the Carestream LLI software and the images stitched using a approved predicate device are acceptable for clinical use.

Condition
Spinal Injuries

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Carestream Digital Radiography Long Length Imaging Manual Stitch Editor Software Data Collection

Resource links provided by NLM:


Further study details as provided by Carestream Health, Inc.:

Primary Outcome Measures:
  • Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate) [ Time Frame: 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.

  • Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational) [ Time Frame: 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.


Enrollment: 76
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


Detailed Description:

The study consists of subject enrollment to collect images in a clinical setting, followed by a review of the stitched images by radiologists or qualified orthopedic surgeons to assess overall usability of the composite images.

This study includes clinical data collection of individual (raw and processed) and composite DR images from a Carestream device using alpha rotation to acquire the images. There is no subject involvement other than obtaining informed consent in order to use patient images and Case Record Forms (CRF), including supporting radiology reports. This study has no effect on clinical treatment and no foreseen risks to enrolled subjects.

The predicate software is currently in place at the sites. Carestream will harvest that data and reconstruct with investigational software offsite. A comparison reader study will be performed upon completion of data collection.

Please note this study is considered to be observational because there were no imaging of subject using investigational device. Subjects requiring standard of care diagnostic images were exposed using the commercially available Cedara system. The images captured on the Cedara system were then re-processed using the Carestream investigational software. Subjects gave informed consent for Carestream to reprocess their image data. They did not require any additional imaging using the investigational device.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects requiring standard of care diagnostic images were exposed using the commercially available Cedara system. The images captured on the Cedara system were then re-processed using the Carestream investigational software. Subjects gave informed consent for Carestream to reprocess their image data. They did not require any additional imaging using the investigational device.
Criteria

Inclusion Criteria:

  • subject has provided informed consent
  • Male or Female who require Long Length Imaging

Exclusion Criteria:

  • Not able or willing to provide Informed Consent, or consent is withdrawn
  • Not able to collect all required case information
  • Patients who are unable to stand
  • Images which are not clinically acceptable to the user
  • Images without a reference object such as a ruler in the image.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592435


Locations
United States, Illinois
Memorial Medical Center
Springfield, Illinois, United States, 62781
United States, Missouri
Heartland Regional Medical Center
St. Joseph, Missouri, United States, 64507
Sponsors and Collaborators
Carestream Health, Inc.
Investigators
Principal Investigator: Larry Kirshner, BSRT Heartland Regional Medical Center
  More Information

Responsible Party: Carestream Health, Inc.
ClinicalTrials.gov Identifier: NCT01592435     History of Changes
Other Study ID Numbers: 8H9323
First Submitted: May 3, 2012
First Posted: May 7, 2012
Results First Submitted: September 14, 2016
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Spinal Injuries
Back Injuries
Wounds and Injuries


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