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

NCT06387485 | Recruiting FDA Device

• 1 other identifier: SR-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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

Keywords

bony tumor

Outcome Measures

Primary Outcomes (1)

• Operative time

  Operative time of surgical procedure based on incision and closure time

  Incision to closure

Secondary Outcomes (3)

• Blood loss

  Incision to closure

• Adverse Events

  Surgery to 90 days post-surgery

• Tumor margin status

  Post-surgery (+3 days)

Study Arms (2)

Standard Imaging

ACTIVE COMPARATOR

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

3D Printed Anatomic Model

EXPERIMENTAL

Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).

Device: 3D Printed Anatomic Model; Diagnostic Test: CT/MRI

Interventions

3D Printed Anatomic Model DEVICE

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

3D Printed Anatomic Model

CT/MRI DIAGNOSTIC_TEST

Standard imaging type for bony tumors

3D Printed Anatomic Model; Standard Imaging

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or nursing women.
• Subjects that have a serious systemic pathology.
• Subjects that have clotting disorders.
• Subjects that have uncontrolled hypertension.
• Subjects that are HIV-positive.
• 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.
• Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
• Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.

Sponsors & Collaborators

• Ricoh USA, Inc.: lead

Study Sites (3)

Kaiser Permanente Oakland Medical Center

Oakland, California, 94611, United States

RECRUITING

William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43212, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma, Ewing; Chondrosarcoma; Osteosarcoma; Histiocytoma, Benign Fibrous; Fibrosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Histiocytoma; Neoplasms, Fibrous Tissue

Central Study Contacts

Alexandra Gormley, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 29, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)