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A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
NCT06387485 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE 3D Printed Anatomic Model
- DIAGNOSTIC_TEST CT/MRI
Study Locations (3)
California
- Kaiser Permanente Oakland Medical Center — Oakland
Michigan
- William Beaumont University Hospital — Royal Oak
Ohio
- The Ohio State University Wexner Medical Center — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06387485
The ClinicalTrials.gov registry entry for NCT06387485 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ricoh USA, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Osteosarcoma appearing as the primary indexed condition, and to 2 interventions — of which 3D Printed Anatomic Model is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06387485 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Michigan, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06387485 about?
NCT06387485 is a clinical study titled "A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning". 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 a...
What is the current status of trial NCT06387485?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-03-01. Estimated completion is 2027-07-31.
What conditions does trial NCT06387485 study?
This clinical trial studies the following conditions: Osteosarcoma, Chondrosarcoma, Sarcoma, Ewing, Fibrosarcoma, Fibrous Histiocytoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06387485?
The interventions under investigation include: 3D Printed Anatomic Model (DEVICE), CT/MRI (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06387485?
This trial is sponsored by Ricoh USA, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06387485 being conducted?
This trial has 3 study locations across California, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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