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Trial Title:
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
NCT ID:
NCT06387485
Condition:
Sarcoma, Ewing
Chondrosarcoma
Osteosarcoma
Fibrous Histiocytoma
Fibrosarcoma
Conditions: Official terms:
Osteosarcoma
Chondrosarcoma
Fibrosarcoma
Histiocytoma
Histiocytoma, Benign Fibrous
Sarcoma, Ewing
Neuroectodermal Tumors, Primitive, Peripheral
Conditions: Keywords:
bony tumor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
3D Printed Anatomic Model
Description:
Patient-specific 3D printed anatomic model for pre-surgical planning
Arm group label:
3D Printed Anatomic Model
Intervention type:
Diagnostic Test
Intervention name:
CT/MRI
Description:
Standard imaging type for bony tumors
Arm group label:
3D Printed Anatomic Model
Arm group label:
Standard Imaging
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 3 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects must be at least 22 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.
Gender:
All
Minimum age:
22 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
William Beaumont University Hospital
Address:
City:
Royal Oak
Zip:
48073
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pamela Sloan, RN, CCRP
Phone:
248-551-6059
Email:
Pamela.Sloan@corewellheath.org
Facility:
Name:
The Ohio State University Wexner Medical Center
Address:
City:
Columbus
Zip:
43212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Herster, BS
Phone:
248-514-4490
Email:
rachel.herster@osumc.edu
Start date:
March 1, 2024
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Ricoh USA, Inc.
Agency class:
Industry
Source:
Ricoh USA, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06387485
