RecruitingNot ApplicableNCT06387485

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

Sponsor

Ricoh USA, Inc.

Enrollment

150 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma Chondrosarcoma Sarcoma, Ewing Fibrosarcoma Fibrous Histiocytoma

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.

Eligibility

Min Age: 13 Years

Plain Language Summary

Simplified for easier understanding

This study compares using a 3D-printed model of a patient's anatomy to standard CT scan images when surgeons plan operations to remove tumors involving bone (such as in the skull, spine, or pelvis). It aims to see if having a physical model improves surgical accuracy and outcomes. **You may be eligible if...** - You are at least 13 years old - You have a tumor growing into bone that requires surgery - You can provide high-quality CT imaging to create a 3D model - You consent to being randomly assigned to either use the 3D model or standard imaging **You may NOT be eligible if...** - You are pregnant or nursing - You have a serious systemic illness - You have a clotting disorder or uncontrolled high blood pressure - You are HIV-positive - Your anatomy has significantly changed since the most recent imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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