A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Operative time
研究概览
简要总结
This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across up to 5 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.
Primary endpoint: Operative time of surgical procedure.
Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.
Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be at least 13 years of age.
- •Subjects must have the ability to provide written informed consent.
- •Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
- •Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.
排除标准
- •Pregnant or nursing women.
- •Subjects that have a serious systemic pathology.
- •Subjects that have clotting disorders.
- •Subjects that have uncontrolled hypertension.
- •Subjects that are HIV-positive.
- •Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning.
- •Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
- •Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.
研究组 & 干预措施
Standard Imaging
Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model
干预措施: CT/MRI (Diagnostic Test)
3D Printed Anatomic Model
Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).
干预措施: 3D Printed Anatomic Model (Device)
3D Printed Anatomic Model
Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).
干预措施: CT/MRI (Diagnostic Test)
结局指标
主要结局
Operative time
时间窗: Incision to closure
Operative time of surgical procedure based on incision and closure time
次要结局
- Tumor margin status(Post-surgery (+3 days))
- Blood loss(Incision to closure)
- Adverse Events(Surgery to 90 days post-surgery)