A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning

Part of paid clinical trials in Oakland, California.

Sponsor
Ricoh USA, Inc.
Study ID
NCT06387485
Status
Recruiting
Apply to this trial

Conditions

  • Chondrosarcoma
  • Fibrosarcoma
  • Fibrous Histiocytoma
  • Osteosarcoma
  • Sarcoma, Ewing

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 3D Printed Anatomic Model — DEVICE
    Patient-specific 3D printed anatomic model for pre-surgical planning
  • CT/MRI — DIAGNOSTIC_TEST
    Standard imaging type for bony tumors

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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
  • 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).

Primary Outcome Measure

Operative time [ Time Frame: Incision to closure ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Oakland Medical CenterOaklandCalifornia94611
Rozhin Lak
[email protected]
925-922-8575
William Beaumont University HospitalRoyal OakMichigan48073
Pamela Sloan, RN, CCRP
[email protected]
248-551-6059
The Ohio State University Wexner Medical CenterColumbusOhio43212
Rachel Herster, BS
[email protected]
248-514-4490

Find similar trials in Oakland, CA

By research site
Kaiser Permanente Oakland Medical Center· Oakland, CAWilliam Beaumont University Hospital· Royal Oak, MIThe Ohio State University Wexner Medical Center· Columbus, OH

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