Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06387485

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Sarcoma, Ewing Chondrosarcoma Fibrosarcoma Fibrous Histiocytoma Histiocytoma Histiocytoma, Benign Fibrous Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Osteosarcoma Sarcoma

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Oakland Medical Center, Oakland, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

3D Printed Anatomic Model

Device

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

CT/MRI

Diagnostic Test

Standard imaging type for bony tumors

Primary outcomes

  1. Operative time

    Time frame: Incision to closure

    Operative time of surgical procedure based on incision and closure time

Secondary outcomes

  1. 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.

  2. 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.

  3. Tumor margin status

    Time frame: Post-surgery (+3 days)

    The proportion of negative tumor margins as determined by laboratory analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Gormley, PhD

CONTACT

[email protected]

484-501-0588

Sponsors and collaborators

Lead sponsor

Ricoh USA, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.