Implantation of Trans-tympanic Aerator Using a Robotic Microsurgical Assistance Tool
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Drain position on the tympanic membrane
研究概览
简要总结
Middle ear surgery is performed in a deep workspace through a narrow approach to the tympanic cavity, either by the external auditory canal, or by drilling the temporal bone. It uses thin and long instruments as a delicate and precise gesture on the ossicular chain or manipulation of very light prostheses is necessary. The results of middle ear procedures relies upon the surgeon experience and his gesture accuracy. For this reason, a robot-based device designed to assist the surgeon during middle ear procedure has been build. The goal of the present protocol is to evaluate the robot in a simple procedure to ensure its safety before using the device in more complex cases.
The precision of the robot during transtympanic tube placement will be evaluated. The following benefits are expected:
- Significantly reduced risk of transtympanic tube on the other side of the eardrum.
- Positioning of the transtympanic tube in the desired tympanic quadrant
- Reduces the size of the entry point to prevent tearing
- Reduced risk of injury to the external auditory canal
Once the safety of use of the robot is demonstrated in this protocol, the goal will be to evaluate it later in more complex surgical gestures in other protocols. The future application of the robot will be the placement of middle ear implant prosthesis in the context of the surgery for cholesteatoma, otosclerosis or insertion of cochlear implants.
详细描述
Description of the population to be studied and justification of its choice:
This study is going to include a single group of patients presenting a vestibular schwannoma that will benefit from an removal by translabyrinthine approach with exclusion from the middle ear under general anesthesia. During this surgery, the tympanic membrane is systematically sacrificed and the inner ear opened with as consequence a complete loss of residual hearing and vertigo for a few days. In this protocol research, the patients will participate by accepting an robot based placement of a tympanic ventilation drain during the surgery before the sacrifice of the tympanic membrane.
All the patients will be adults, living in France, benefiting from the cover of the French health care system. The people participating to the research will have to give their consent to participate to the study.
Name and brief description of one or several experimental medical devices:
The concept of the device RobOtol® is based on a teleoperated system with 6 degrees of freedom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient candidate for exclusion of the middle ear when performing a translabyrinthine approach during a vestibular schwannoma surgery
- •Patient over 18 years old
排除标准
- •Patient with psychomotor retardation or behavioral problems that preclude clinical examination
- •Patient with an external auditory canal diameter of less than 3 mm
- •Patient participating in another interventional clinical trial
- •Breastfeeding or pregnant woman
- •Patient not residing in France
- •Patient under tutorship / guardianship or under security measure
- •Patient who has not signed a written consent
- •Patient not benefiting from french national health insurance system
结局指标
主要结局
Drain position on the tympanic membrane
时间窗: one day
Video recording of the procedure and tympanic membrane collection and microscopic analysis will used to assess drain position
次要结局
- The number of contact between the cutaneous cover of the external auditory canal and the instrument of the robot(one day)
- Duration of installation of the robot and the procedure(one day)
- The occurence of a bleeding intraoperative from the eardrum or from the external auditory canal(one day)
- The occurence of a lesion of the tympanic membrane except the section necessary for the placement of the drain (tympanic perforation, accidental tear)(one day)