NCT06387485

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Ricoh USA, Inc. · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-04-30
• Completion: 2027-07-31
• First posted: 2024-04-29
• Last updated: 2026-02-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study