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

NCT06387485 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-06

No results posted yet for this study

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

Interventions

DEVICE

3D Printed Anatomic Model

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

DIAGNOSTIC_TEST

CT/MRI

Standard imaging type for bony tumors

Sponsors & Collaborators

  • Ricoh USA, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2027-04-30
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06387485 on ClinicalTrials.gov