Clinical Validation and Testing of Percutaneous Cochlear Implantation

经皮人工耳蜗植入的临床验证和测试

• 批准号: 9087221
• 负责人: ROBERT F LABADIE
• 金额: $ 59.94万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-05 至 2018-04-05
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9087221
• 关键词: Abdomen; Acoustic Nerve; Adult; American; Anatomy; Caliber; Clinical; Clinical Protocols; Clinical Trials; Cochlea; Cochlear Implants; Cochlear implant procedure; Computer software; Cost Measures; Custom; Development; Devices; Diagnosis; Dissection; Electrodes; Endoscopes; Equipment; Excision; Exhibits; External Ear; Facial nerve structure; Funding; Goals; Guidelines; Head; Healed; Hearing; Hearing Impaired Persons; Hour; Image; Implanted Electrodes; Individual; Injury; Institutional Review Boards; Intervention; Labyrinth; Laparoscopic Surgical Procedures; Lateral; Local anesthesia; Location; Mastoid process; Measurable; Measures; Medical Device; Operating Rooms; Operative Surgical Procedures; Patients; Peer Review; Phase; Phase II Clinical Trials; Postoperative Period; Procedures; Progress Reports; Protocols documentation; Publications; Randomized Clinical Trials; Recovery; Recovery Room; Research; Resected; Risk; Safety; Scala Tympani; Services; Surface; Surrogate Endpoint; Techniques; Technology; Testing; Time; Tissues; United States; United States National Institutes of Health; Validation; Visit; Visual; Work; bone; cost; cranium; design; healing; hearing impairment; image guided; individual patient; instrument; minimally invasive; novel strategies; phase 1 study; phase 2 study; randomized trial; research clinical testing; standard of care; tool; trial comparing; usability

DESCRIPTION (provided by applicant): Access to the inner ear, specifically the cochlea, is required for cochlear implant (CI) surgery, in which an electrode array is used to stimulate the auditory nerve and allow deaf people to hear. More than 240,000 CIs have been placed worldwide with approximately 70,000 performed in the USA. Projections indicate that up to 750,000 Americans with severe hearing loss may benefit from CI. In our ongoing NIH-funded project (R01 DC008408), we have demonstrated the feasibility of percutaneous cochlear implantation (PCI). PCI reduces CI surgery to a single pass of a drill from the lateral skull surface to the cochlea. The drill path is planned and executed using image-guided technology so as to avoid vital adjacent anatomy (e.g. the facial nerve) and hit the target-the scala tympani of the cochlea. In clinical trials we have validated the PCI technique on 31 adult patients with statistical projections indicating avoidance of vital anatomy at a rate similar to that of traditioal surgery. Furthermore, we have begun implementation of PCI by developing instruments and techniques for drilling and have performed incrementally deeper drilling on 10 additional patients the most recent of which had complete PCI performed. The potential benefits of PCI are many including less tissue removal and shorter time of surgical intervention. In the attached submission, we propose to build on our successful development of PCI and explore potential benefits by (i) extending our Phase I study by one year in order to produce a robust clinical protocol and (ii) carrying out a Phase II study consisting of a randomized clinical trial comparing PCI to traditional CI surgery. More specifically, during Phase I we will (a) further refine our imaging and planning software to optimize accuracy and usability, (b) implement redundant safety checks to minimize risk of injury to the facial nerve, (c) investigate three options for creating the opening into the cochlea via the PCI track and picking the best one for the final protocol, (d) investigate the use of endoscopes for verification of accurate targeting of the scala tympani component of the cochlea, and (e) finalize design of an insertion tool for final CI electrode placement. In the Phase II randomized trial we will compare, head-to-head, traditional CI and PCI surgery with formal endpoints being (a) amount of tissue resected during intervention and (b) time of intervention. These formal metrics will be used to assess (a) the impact of the procedure on individual patients, which may portend quicker recovery and quicker CI activation for PCI patients, and (b) the overall cost of intervention which despite the need for additional equipment may be cheaper for PCI due to decreased operative time. While our study is set up to demonstrate statistically significant reductions in both volume of tissue removed and time of intervention, we will remain open to other potential benefits (e.g. more consistent electrode placement in the scala tympani with PCI). If our study is successful, we posit that PCI will become the preferred technique for CI.

描述（由申请人提供）：耳蜗植入（CI）手术需要进入内耳，特别是耳蜗，其中电极阵列用于刺激听觉神经并使聋人能够听到。全球已放置超过240，000个CI，其中约70，000个在美国进行。预测表明，多达750，000名患有严重听力损失的美国人可能从CI中受益。在我们正在进行的NIH资助项目（R 01 DC 008408）中，我们已经证明了经皮耳蜗植入（PCI）的可行性。PCI将CI手术减少为从侧颅骨表面到耳蜗的单次钻孔。使用图像引导技术规划和执行钻孔路径，以避免重要的邻近解剖结构（例如面神经）并击中目标-耳蜗的鼓阶。在临床试验中，我们已经在31例成人患者中验证了PCI技术，统计预测表明避免重要解剖结构的比率与传统手术相似。此外，我们已经开始通过开发钻孔工具和技术实施PCI，并对另外10名患者进行了逐渐加深的钻孔，其中最近的患者进行了完全PCI。PCI的潜在益处有很多，包括较少的组织切除和较短的手术干预时间。在随附的提交资料中，我们建议在成功开发PCI的基础上，通过以下方式探索潜在获益：（i）将I期研究延长一年，以制定稳健的临床方案;（ii）开展II期研究，包括随机临床试验，比较 PCI到传统CI手术。更具体地说，在第一阶段，我们将（a）进一步完善我们的成像和规划软件，以优化准确性和可用性，（B）实施冗余安全检查，以最大限度地减少面神经损伤的风险，（c）研究通过PCI轨道创建耳蜗开口的三种选择，并为最终方案选择最佳方案，（d）调查使用内窥镜来验证阶的准确定位 （e）完成用于最终Cl电极放置的插入工具的设计。在II期随机试验中，我们将比较头对头、传统CI和PCI手术，正式终点为（a）干预期间切除的组织量和（B）干预时间。这些正式指标将用于评估（a）手术对个体患者的影响，这可能预示着PCI患者的更快恢复和更快CI激活，以及（B）尽管需要 由于减少了手术时间，额外的设备对于PCI来说可能更便宜。虽然我们的研究旨在证明切除的组织体积和干预时间在统计学上显著减少，但我们仍将对其他潜在受益持开放态度（例如，PCI在鼓阶中的电极放置更一致）。如果我们的研究成功，我们认为PCI将成为CI的首选技术。