NCT06387485 A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
| NCT ID | NCT06387485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ricoh USA, Inc. |
| Condition | Sarcoma, Ewing |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-03-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06387485 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying Sarcoma, Ewing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06387485 currently recruiting?
Yes, NCT06387485 is actively recruiting participants. Contact the research team at alexandra.gormley@ricoh-usa.com for enrollment information.
Where is the NCT06387485 trial being conducted?
This trial is being conducted at Oakland, United States, Royal Oak, United States, Columbus, United States.
Who is sponsoring the NCT06387485 clinical trial?
NCT06387485 is sponsored by Ricoh USA, Inc.. The trial plans to enroll 150 participants.