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.
250 studies on the registry are indexed under Sarcoma, Ewing; 69 are open to participants now.
This study's planned enrollment of 150 is above the median of 36 across 204 interventional studies indexed under Sarcoma, Ewing.
Browse Sarcoma, Ewing studies →This is the only study on the registry with Ricoh USA, Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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