Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing

Kathleen McGreevy

Status: Enrolling

Conditions: Intracranial Neoplasm; Pelvic Bone Neoplasm; Sarcoma

Treatments: Device: 3D printer applications

Study type: Interventional

Funder types: Other

Identifiers

NCT06291662

PRECISE_IC

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 7 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Pelvic bone neoplasm

Experimental group

Description:

Patients with primary tumor of the pelvic bone; Primary meta-diaphysial tumor of the long bones; squamous cell carcinoma of the oral cavity involving the maxillary upper and/or lower.

Treatment:

Device: 3D printer applications

Sarcoma pediatric patients

Experimental group

Description:

Patients with primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper and lower limbs; brain tumor.

Treatment:

Device: 3D printer applications

Intracranial oncologic pathology

Experimental group

Description:

Patients with intracranial oncologic pathology with bone involvement and lesions of the skull theca primary or secondary.

Treatment:

Device: 3D printer applications