Health Trials

About this trial

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

Qualifiers

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.

Disqualifiers

Pregnant or nursing women.

Subjects that have a serious systemic pathology.

Subjects that have clotting disorders.

Subjects that have uncontrolled hypertension.

Trial design

Treatments tested in this trial

  • 3D Printed Anatomic Model
  • CT/MRI

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

3
Kaiser Permanente Oakland Medical Center94611, OaklandCalifornia, United States
William Beaumont University Hospital48073, Royal OakMichigan, United States
The Ohio State University Wexner Medical Center43212, ColumbusOhio, United States

Sponsors and collaborators

Ricoh USA, Inc.

Lead sponsor

Source ClinicalTrials.gov