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Clinical Trial 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 3 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06387485
Study type Interventional
Source Ricoh USA, Inc.
Contact Alexandra Gormley, PhD
Phone 484-501-0588
Email alexandra.gormley@ricoh-usa.com
Status Recruiting
Phase N/A
Start date March 1, 2024
Completion date April 1, 2025

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