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A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Sponsor: Ricoh USA, Inc.
Summary
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.
Key Details
Gender
All
Age Range
13 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-03-01
Completion Date
2027-07-31
Last Updated
2026-02-06
Healthy Volunteers
No
Interventions
3D Printed Anatomic Model
Patient-specific 3D printed anatomic model for pre-surgical planning
CT/MRI
Standard imaging type for bony tumors
Locations (3)
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