Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 5
- 主要终点
- Device feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •inoperability;
- •presence of pathological fractures.
结局指标
主要结局
Device feasibility
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Kathleen McGreevy
Chief Operating Officer, Meyer Children's Research Institute
Meyer Children's Hospital IRCCS