A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning

February 4, 2026 updated by: Ricoh USA, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente Oakland Medical Center
        • Contact:
    • Michigan
      • Royal Oak, Michigan, United States, 48073
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects must be at least 13 years of age.
  2. Subjects must have the ability to provide written informed consent.
  3. Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
  4. Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.

Exclusion Criteria:

  1. Pregnant or nursing women.
  2. Subjects that have a serious systemic pathology.
  3. Subjects that have clotting disorders.
  4. Subjects that have uncontrolled hypertension.
  5. Subjects that are HIV-positive.
  6. Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning.
  7. Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
  8. Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Imaging
Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model
Diagnostic test: CT/MRI
Standard imaging type for bony tumors
Experimental: 3D Printed Anatomic Model
Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).
Diagnostic test: CT/MRI
Standard imaging type for bony tumors
Device: 3D Printed Anatomic Model
Patient-specific 3D printed anatomic model for pre-surgical planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Incision to closure
Operative time of surgical procedure based on incision and closure time
Incision to closure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: Incision to closure
Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL.
Incision to closure
Adverse Events
Time Frame: Surgery to 90 days post-surgery
The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review.
Surgery to 90 days post-surgery
Tumor margin status
Time Frame: Post-surgery (+3 days)
The proportion of negative tumor margins as determined by laboratory analysis.
Post-surgery (+3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ricoh USA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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