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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 3, 2012
Last Updated Date	March 25, 2013
Start Date ^ICMJE	April 2011
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 25, 2013)	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
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01592435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol
Official Title ^ICMJE	Carestream Digital Radiography Long Length Imaging Manual Stitch Editor Software Data Collection
Brief Summary	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.
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Prospective enrollment from the diagnostic schedule
Condition ^ICMJE	Long Length Imaging
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	75
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01592435
Other Study ID Numbers ^ICMJE	8H9323
Has Data Monitoring Committee	No
Responsible Party	Carestream Health, Inc.
Study Sponsor ^ICMJE	Carestream Health, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Carestream Health, Inc.
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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