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临床试验/NCT03297736
NCT03297736Unknown不适用

Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts

Nitinetics LLC2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Cost savings

研究概览

简要总结

Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of two middle ear implants. The rationale is to complete a pilot study of the technology with a small number of designs. Each implant will be commonly used, in the public domain, and recreated by the CAD/CAM software.

详细描述

Conventional middle ear prosthetic prosthetics, including total ossicular replacement prostheses (TORPs) and partial ossicular replacement prostheses (PORPs) are expensive, require large inventories for otologic surgery services, and carry the risk of extrusion or rejection. Autologous bone and cartilage can be used for many of these applications, but it requires expensive operating room time for carving to the appropriate shape and size.

The above considerations led to the concept of subtractive 3D CAD/CAM (computer assisted design/computer assisted manufacture) to produce accurate bone and cartilage autografts on demand in the operating room. Such a technology is hypothesized to save money by reducing operating room time, and reducing the need for expensive inventories of various shapes, sizes, and types of prosthetic devices. Since autologous materials are hypothesized to be less likely to extrude or cause other problems such as infection, this could also reduce costs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction

排除标准

  • congenital anomalies

结局指标

主要结局

Cost savings

时间窗: perioperative

operative costs compared between treatment groups utilizing total operative time in minutes

次要结局

  • ABG(preoperative; 6weeks, 3 months, and 6 months postoperatively.)
  • Number of participants that experience device rejection(6 months)
  • Number of participants with treatment related adverse events as assessed by CTCAE v4.0(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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