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Official title A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
ClinicalTrials.gov ID: NCT06387485
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 and older
You may be able to join if
- people must be at least 13 years of age.
- people must have the ability to provide written informed consent.
- people must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and...
- people must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.
You likely can't join if
- Pregnant or nursing women.
- people that have a serious systemic pathology.
- people that have clotting disorders.
- people that have uncontrolled hypertension.
- people that are HIV-positive.
- people that are unable to be assigned by chance; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical...
See the full eligibility criteria
- people must be at least 13 years of age.
- people must have the ability to provide written informed consent.
- people must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
- people must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.
- Pregnant or nursing women.
- people that have a serious systemic pathology.
- people that have clotting disorders.
- people that have uncontrolled hypertension.
- people that are HIV-positive.
- people that are unable to be assigned by chance; 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.
The study team makes the final eligibility decision.
Where it's taking place
- Oakland, California, United States
- Royal Oak, Michigan, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oakland, California, United States; Royal Oak, Michigan, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.