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

Not Applicable

Recruiting

• Conditions: Intracranial Neoplasm; Pelvic Bone Neoplasm; Sarcoma

• Registration Number: NCT06291662
• Lead Sponsor: Kathleen McGreevy

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Device feasibility	through study completion, an average of 1 year	Proportion of failed surgeries due to a positive or contaminated finding of the margin of bone resection on final histological examination. verified by comparing the expected outcome (i.e., planning output) and the actual outcome (on the postoperative CT scan).
3D model feasibility for pre-surgical making decisions	through study completion, an average of 1 year	Number of cases in which the time interval between prescription and delivery of the device exceeds 20 days
Surgical time	through study completion, an average of 1 year	Number of procedures in which the surgical outcome can be considered optimal (taking planning as a reference) by comparing CT images and evaluating the margins at final histologic analysis.

Trial Locations

Locations (3)

Azienda Ospedaliero-Universitaria Careggi (AOUC); 🇮🇹 Firenze, Italy

Meyer Children's Hospital IRCCS; 🇮🇹 Firenze, Italy

Azienda Ospedaliero Universitaria Senese (AOUS); 🇮🇹 Siena, Italy