NCT06387485Recruiting
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 18 Apr 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Ricoh USA, Inc.
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT06387485
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Mar 2024 to the primary completion date, 30 Apr 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.
Other illness
- Subjects that have clotting disorders.
- Subjects that have uncontrolled hypertension.
- Subjects that are HIV-positive.
Other
- Pregnant or nursing women.
- Subjects that have a serious systemic pathology.
- Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
Who the study is looking for
- 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.
Age in the registry: 13 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Kaiser Permanente Oakland Medical Center Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| William Beaumont University Hospital Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.