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Trial Title:
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
NCT ID:
NCT06291662
Condition:
Sarcoma
Intracranial Neoplasm
Pelvic Bone Neoplasm
Conditions: Official terms:
Neoplasms
Bone Neoplasms
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Oncologic patients
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
3D printer applications
Description:
Patients will undergo TC/MRI as per routinary care. Custom 3D-devices will be printed on
the basis of these images. The device will be used to establish pre-operative surgical
options in terms of tissue/bones demolition/reconstruction.
Arm group label:
Intracranial oncologic pathology
Arm group label:
Pelvic bone neoplasm
Arm group label:
Sarcoma pediatric patients
Summary:
Technologies 3D are demonstrating enormous potential for innovation in the field of
surgery,introducing the concept of "treatment customization" (from planning surgery to
implant design and manufacturing) on the patient's anatomy, simply by taking advantage of
the patient's own common diagnostic images and the flexibility of 3D printing. In fact,
this new construction technology allows the construction of the complex anatomical
geometries with economy, simplicity and on scales of production unattainable by other
traditional technologies. This new construction technology allows, in fact, the
construction of complex anatomical geometries with economy, simplicity and on scales of
production unattainable by other traditional technologies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Primary tumor of the pelvic bone Primary meta-diaphysial tumor of the long bones;
squamous cell carcinoma of the oral cavity in the upper and/or lower jaw. over 10
years of age
- Primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper
and lower limbs; brain tumor aged 7-18 years
- Intracranial oncologic pathology with bone involvement and lesions of the skull
theca primary or secondary aged 18-70years
- signed informed consent form
Exclusion Criteria:
- inoperability;
- presence of pathological fractures.
Gender:
All
Minimum age:
7 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Azienda Ospedaliero-Universitaria Careggi (AOUC)
Address:
City:
Firenze
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Meyer Children's Hospital IRCCS
Address:
City:
Firenze
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Federico Mussa, MD
Email:
federico.mussa@meyer.it
Facility:
Name:
Azienda Ospedaliero Universitaria Senese (AOUS)
Address:
City:
Siena
Country:
Italy
Status:
Active, not recruiting
Start date:
January 1, 2021
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Kathleen McGreevy
Agency class:
Other
Source:
Meyer Children's Hospital IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06291662