Recruiting

3D Printed Models

Sponsor:

Ricoh USA, Inc.

Code:

NCT06387485

Conditions

Sarcoma, Ewing

Chondrosarcoma

Osteosarcoma

Fibrous Histiocytoma

Fibrosarcoma

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

3D Printed Anatomic Model

CT/MRI

Study Details

Brief 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.

Conditions

Sarcoma, Ewing

Chondrosarcoma

Osteosarcoma

Fibrous Histiocytoma

Fibrosarcoma

Study ID

NCT06387485

Start date

Mar 1, 2024

Status verified date

Feb, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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).

Interventions

3D Printed Anatomic Model

Patient-specific 3D printed anatomic model for pre-surgical planning

CT/MRI

Standard imaging type for bony tumors

Primary outcome measure

  • Operative time [ Time Frame: Incision to closure ]

Central Contacts and Locations

Central contacts

Alexandra Gormley, PhD

484-501-0588alexandra.gormley@ricoh-usa.com

Locations

Kaiser Permanente Oakland Medical Center

Recruiting

Oakland, California, United States, 94611

Contacts

Rozhin Lak

925-922-8575Rozhin.X.Lak@kp.org

William Beaumont University Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Pamela Sloan, RN, CCRP

248-551-6059Pamela.Sloan@corewellheath.org

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Rachel Herster, BS

248-514-4490rachel.herster@osumc.edu

More Information

Sponsor

Ricoh USA, Inc.

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • bony tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ricoh USA, Inc. on 2026-02-06.