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Purpose

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

Eligibility

Eligible Ages
Over 13 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard Imaging 		Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model
  • Diagnostic Test: CT/MRI
    Standard imaging type for bony tumors
Experimental
3D Printed Anatomic Model 		Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).
  • Device: 3D Printed Anatomic Model
    Patient-specific 3D printed anatomic model for pre-surgical planning
  • Diagnostic Test: CT/MRI
    Standard imaging type for bony tumors

Recruiting Locations

Kaiser Permanente Oakland Medical Center
Oakland 5378538, California 5332921 94611
Contact:
Rozhin Lak
925-922-8575
Rozhin.X.Lak@kp.org

William Beaumont University Hospital
Royal Oak 5007804, Michigan 5001836 48073
Contact:
Pamela Sloan, RN, CCRP
248-551-6059
Pamela.Sloan@corewellheath.org

The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43212
Contact:
Rachel Herster, BS
248-514-4490
rachel.herster@osumc.edu

More Details

Status
Recruiting
Sponsor
Ricoh USA, Inc.

Study Contact

Alexandra Gormley, PhD
484-501-0588
alexandra.gormley@ricoh-usa.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.