This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
May 3, 2012
March 9, 2017
April 2011
December 2012   (Final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT01592435 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol
Carestream Digital Radiography Long Length Imaging Manual Stitch Editor Software Data Collection
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Spinal Injuries
Not Provided
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.

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
December 2012
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01592435
8H9323
No
Not Provided
No
Not Provided
Carestream Health, Inc.
Carestream Health, Inc.
Not Provided
Principal Investigator: Larry Kirshner, BSRT Heartland Regional Medical Center
Carestream Health, Inc.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP