Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol

NCT01592435 | Completed Results

• 1 other identifier: 8H9323
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Injuries

Outcome Measures

Primary Outcomes (2)

• Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate)

  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.

  5 weeks after completion of data collection

• Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational)

  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.

  5 weeks after completion of data collection

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• subject has provided informed consent
• Male or Female who require Long Length Imaging

You may not qualify if:

• Not able or willing to provide Informed Consent, or consent is withdrawn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

Sponsors & Collaborators

• Carestream Health, Inc.: lead

Study Sites (2)

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64507, United States

Location

MeSH Terms

Conditions

Spinal Injuries

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries

Results Point of Contact

• Title: Susan Pate, MS, RN, RAC, Senior Manager, Clinical Affairs
• Organization: Carestream Health, Inc.

susan.pate@carestream.com

585-627-6557

Study Officials

• Larry Kirshner, BSRT

  Heartland Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 6, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)