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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 25, 2013
Last verified: March 2013

May 3, 2012
March 25, 2013
April 2011
December 2012   (final data collection date for primary outcome measure)
Demonstrate Acceptability for Clinical Use [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Demonstrate that the images stitched using the Carestream LLI software and the images stitched using a cleared predicate device are acceptable for clinical use
Not Provided
Complete list of historical versions of study NCT01592435 on ClinicalTrials.gov Archive Site
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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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Prospective enrollment from the diagnostic schedule

Long Length Imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
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.
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01592435
8H9323
No
Carestream Health, Inc.
Carestream Health, Inc.
Not Provided
Not Provided
Carestream Health, Inc.
March 2013

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