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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 3D printed models in planning surgeries to remove tumors that involve bones. This randomized controlled study will compare the effectiveness of using 3D printed models along with imaging to planning surgery using only imaging techniques such as CT or MRI. The goal is to improve surgical outcomes for patients with bone-invading tumors such as sarcoma and osteosarcoma across multiple centers and sites. Participants will be randomly assigned to one of two groups. One group will have their tumor excision planned using standard imaging techniques only, while the other group will have surgery planned with the help of patient-specific 3D printed anatomic models along with imaging. Both groups will undergo tumor removal surgery, with the study lasting about 12 months and including up to 150 subjects. Throughout the study, researchers will measure the time taken for the surgical procedure from incision to closure as the main outcome. They will also monitor blood loss during surgery, any adverse events up to 90 days after surgery, and whether the tumor was completely removed with negative margins. Additional assessments will include how easy the surgical planning was, any changes made to the plan, and the surgeon's satisfaction. Participants will undergo required imaging and surgery, with follow-up to assess safety and outcomes.
CONDITIONS
Brief 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 tumors invading bone requiring surgical excision, including craniomaxillofacial, spine, long bone, or pelvis areas.
- Subjects must be willing to undergo quality imaging (CT or MRI) 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 hypertension.
- 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 surgical or study candidates due to medical, social, or psychological reasons.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo imaging with CT or MRI to assess tumors and enable planning.
1 visit (in-person)
Duration - Up to 2 weeks
Participants receive pre-surgical planning using either standard imaging alone or imaging plus a patient-specific 3D printed anatomic model before tumor excision surgery.
1 visit (in-person) for surgical planning
Duration - Until discharge
Participants undergo tumor excision surgery based on their assigned pre-operative planning method.
1 visit (in-person) for surgery
Duration - Up to 90 days
Participants are monitored for recovery and adverse events for up to 90 days after surgery.
Approximately 3 visits (in-person)
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
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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