An interventional study of 3D Printed Anatomic Model and CT/MRI in Sarcoma, Ewing, Chondrosarcoma and Osteosarcoma, sponsored by Ricoh USA, Inc.. Recruiting at 3 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Ricoh USA, Inc. · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model
Diagnostic Test: CT/MRI
Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).
Device: 3D Printed Anatomic Model · Diagnostic Test: CT/MRI
Patient-specific 3D printed anatomic model for pre-surgical planning
Standard imaging type for bony tumors
Operative time
Operative time of surgical procedure based on incision and closure time
Time frame: Incision to closure
Blood loss
Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL.
Time frame: Incision to closure
Adverse Events
The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review.
Time frame: Surgery to 90 days post-surgery
Tumor margin status
The proportion of negative tumor margins as determined by laboratory analysis.
Time frame: Post-surgery (+3 days)
Plan to share: No
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