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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06387485
Other study ID # SR-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date April 1, 2025

Study information

Verified date April 2024
Source Ricoh USA, Inc.
Contact Alexandra Gormley, PhD
Phone 484-501-0588
Email alexandra.gormley@ricoh-usa.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date April 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States William Beaumont University Hospital Royal Oak Michigan

Sponsors (1)

Lead Sponsor Collaborator
Ricoh USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operative time Operative time of surgical procedure based on incision and closure time Incision to closure
Secondary Blood loss Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL. Incision to closure
Secondary Adverse Events The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review. Surgery to 90 days post-surgery
Secondary Tumor margin status The proportion of negative tumor margins as determined by laboratory analysis. Post-surgery (+3 days)
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