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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

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