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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
History of Changes
  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
Long Length Imaging

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:

MedlinePlus related topics: X-Rays
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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


Enrollment: 75
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Prospective enrollment from the diagnostic schedule

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
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Carestream Health, Inc.
ClinicalTrials.gov Identifier: NCT01592435     History of Changes
Other Study ID Numbers: 8H9323
Study First Received: May 3, 2012
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carestream Health, Inc.:
LLI

ClinicalTrials.gov processed this record on May 19, 2013