Clinical trial · Interventional
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chondrosarcoma | Chondrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Fibrosarcoma | Fibrosarcoma | ONTOLOGY_EXACT | 0.90 |
| Fibrous Histiocytoma | Fibrous Histiocytoma | ONTOLOGY_EXACT | 0.98 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma, Ewing | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D Printed Anatomic Model | Device | — | UNRESOLVED |
| CT/MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Imaging
- description
- Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model
- interventionNames
- Diagnostic Test: CT/MRI
- type
- EXPERIMENTAL
- label
- 3D Printed Anatomic Model
- description
- Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).
- interventionNames
- Device: 3D Printed Anatomic Model
- Diagnostic Test: CT/MRI
Primary outcomes (1)
- measure
- Operative time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must be at least 13 years of age. 2. Subjects must have the ability to provide written informed consent. 3. Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis. 4. Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model. Exclusion Criteria: 1. Pregnant or nursing women. 2. Subjects that have a serious systemic pathology. 3. Subjects that have clotting disorders. 4. Subjects that have uncontrolled hypertension. 5. Subjects that are HIV-positive. 6. 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. 7. Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable). 8. Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.
References
Publications (0)
Data not yet available