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

Carestream

Status: Completed

Conditions: Spinal Injuries

Study type: Observational

Funder types: Industry

Identifiers

NCT01592435

8H9323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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• Not able or willing to provide Informed Consent, or consent is withdrawn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.

Trial design

76 participants in 1 patient group

Pred. & Invest.-All Study Participants

Description:

Cedera AccuStitch Software is standard of care software currently used at sites. Carestream DR LLI software is investigational software used for reconstruction.