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RECRUITING
NCT06387485
NA

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

Sponsor: Ricoh USA, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

13 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-03-01

Completion Date

2027-07-31

Last Updated

2026-02-06

Healthy Volunteers

No

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

Locations (3)

Kaiser Permanente Oakland Medical Center

Oakland, California, United States

William Beaumont University Hospital

Royal Oak, Michigan, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States