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This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across up to 5 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging. Primary endpoint: Operative time of surgical procedure. Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins. Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
Kaiser Permanente Oakland Medical Center
Oakland, California, United States
William Beaumont University Hospital
Royal Oak, Michigan, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Start Date
March 1, 2024
Primary Completion Date
April 30, 2027
Completion Date
July 31, 2027
Last Updated
February 6, 2026
150
ESTIMATED participants
3D Printed Anatomic Model
DEVICE
CT/MRI
DIAGNOSTIC_TEST
Lead Sponsor
Ricoh USA, Inc.
NCT05039801
NCT07479732
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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