Actively Recruiting
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Led by Ricoh USA, Inc. · Updated on 2026-02-06
150
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be at least 13 years of age
- Subjects must be able to provide written informed consent
- Subjects must have tumor(s) invading bone requiring surgical excision, including craniomaxillofacial, spine, long bone, or pelvis tumors
- Subjects must agree to have quality cross-sectional imaging for 3D model development
You will not qualify if you...
- Pregnant or nursing women
- Subjects with serious systemic diseases
- Subjects with clotting disorders
- Subjects with uncontrolled high blood pressure
- Subjects who are HIV-positive
- Subjects unable to be randomized due to surgical team preference
- Subjects whose anatomy has changed substantially since imaging was obtained
- Subjects considered poor candidates for surgery or study due to medical, social, or psychological reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Kaiser Permanente Oakland Medical Center
Oakland, California, United States, 94611
Actively Recruiting
2
William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
3
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43212
Actively Recruiting
Research Team
A
Alexandra Gormley, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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