NCT06387485 · Ricoh USA, Inc.
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
What this study is about
This forward-looking, multi-center, randomly assigned controlled study aims to assess the effectiveness 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.
View original scientific description
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.
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
Primary outcome measures
Operative time
Time frame: Incision to closure
Operative time of surgical procedure based on incision and closure time
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects must be at least 13 years of age.
- Subjects must have the ability to provide written informed consent.
- Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
- Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.
Exclusion criteria
- Pregnant or nursing women.
- Subjects that have a serious systemic pathology.
- Subjects that have clotting disorders.
- Subjects that have uncontrolled hypertension.
- Subjects that are HIV-positive.
- Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning.
- Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
- Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.
Where
- Oakland, California
- Royal Oak, Michigan
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2026 · Source of record for eligibility and locations