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Procedure
3D Printed Models for Bone Cancer
N/A
Recruiting
Research Sponsored by Ricoh USA, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be at least 22 years of age
Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis
Must not have
Subjects that have a serious systemic pathology
Subjects that have clotting disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgery to 90 days post-surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effectiveness of using 3D printed models in planning surgeries to remove tumors from bones in the body. The study will last for about a year and involve 150 participants from three
Who is the study for?
This trial is for individuals with certain bone-related tumors, including Fibrous Histiocytoma and Osteosarcoma. Participants should be suitable candidates for surgery to remove their tumor. The study excludes specific details on who can't join.
What is being tested?
The study compares the use of 3D printed models plus imaging versus imaging alone (like CT/MRI scans) in planning surgeries to remove bone tumors. It aims to see if 3D models can shorten surgery time and improve other outcomes like blood loss and surgical satisfaction.
What are the potential side effects?
Since this trial focuses on pre-operative planning methods rather than medications, it does not directly involve drug side effects. However, there may be risks associated with the surgical procedures themselves.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 22 years old.
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My cancer has spread to my bones and needs surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious illness affecting my whole body.
Select...
I have a blood clotting disorder.
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My high blood pressure is not under control.
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I am HIV-positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ incision to closure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~incision to closure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Operative time
Secondary study objectives
Adverse Events
Blood loss
Tumor margin status
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 3D Printed Anatomic ModelExperimental Treatment2 Interventions
Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).
Group II: Standard ImagingActive Control1 Intervention
Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CT/MRI
2009
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Ricoh USA, Inc.Lead Sponsor