Clinical Validation and Testing of Percutaneous Cochlear Implantation

描述(由申请人提供)：人工耳蜗术需要接触到内耳，特别是耳蜗，在这种手术中，使用电极阵列来刺激听神经，使聋人能够听到。已在全球放置了超过240,000个CI，其中约70,000个在美国执行。预测表明，多达75万患有严重听力损失的美国人可能会从CI中受益。在我们正在进行的NIH资助的项目(R01DC008408)中，我们已经证明了经皮人工耳蜗术(PCI)的可行性。经皮冠状动脉介入术将CI手术简化为从侧颅表面到耳蜗单一次钻孔。钻探路径的规划和执行使用了图像引导技术，以避免重要的邻近解剖(例如面神经)，并击中目标-耳蜗鼓阶。在临床试验中，我们已经在31名成人患者身上验证了经皮冠状动脉介入治疗技术，统计预测表明，避免重要解剖的比率与传统手术相似。此外，我们已经通过开发钻探仪器和技术开始实施经皮冠状动脉介入治疗，并对另外10名患者进行了逐渐加深的钻探，其中最新的患者进行了完全经皮冠状动脉介入治疗。经皮冠状动脉介入治疗的潜在好处很多，包括更少的组织切除和更短的手术时间。在附上的意见书中，我们建议在我们成功开发经皮冠状动脉介入治疗的基础上，通过(I)将我们的第一阶段研究延长一年以产生可靠的临床方案，以及(Ii)进行由随机临床试验比较组成的第二阶段研究，以探索潜在的好处 经皮冠状动脉介入治疗对传统脑梗塞手术的影响。更具体地说，在第一阶段，我们将(A)进一步改进我们的成像和规划软件，以优化准确性和可用性，(B)实施冗余的安全检查，以最大限度地减少对面神经的损伤风险，(C)研究通过经皮冠状动脉腔内成形术进入耳蜗口的三种选择，并为最终方案选择最佳方案，(D)调查使用内窥镜来验证Scala的准确靶向 (E)完成用于最终CI电极放置的插入工具的设计。在第二阶段随机试验中，我们将面对面地比较传统的CI和PCI手术，正式的终点是(A)介入期间切除的组织数量和(B)介入的时间。这些正式指标将被用来评估(A)手术对个别患者的影响，这可能预示着PCI患者更快的恢复和更快的CI激活，以及(B)尽管需要 由于手术时间的减少，额外的设备对于经皮冠状动脉介入治疗来说可能更便宜。虽然我们的研究旨在证明组织切除的体积和介入时间在统计上都有显著减少，但我们仍将对其他潜在的好处持开放态度(例如，通过经皮冠状动脉介入治疗在鼓阶放置更一致的电极)。如果我们的研究成功，我们认为经皮冠状动脉介入治疗将成为脑梗塞的首选技术。 公共卫生相关性：在美国，大约有70,000名聋人受益于人工耳蜗植入(CI)，这是一种2小时以上的手术，包括移除外耳后面的一部分骨头，到达内耳，即耳蜗处，并放置一根电线刺激耳蜗线，以使其听力得以恢复。使用图像引导手术技术-类似于用于提供地理方向的GPS技术-我们已经证明，通过跟踪和控制钻头的路径，从而使一次钻探即可到达耳蜗处，可以实现侵入性小得多的手术方法--我们将这种技术称为经皮人工耳蜗术(PCI)。在对这项技术进行了广泛的研究后，我们最近进行了世界上第一例经皮冠状动脉介入治疗，现在建议通过一项随机临床试验将经皮冠状动脉介入治疗与传统的脑梗塞手术进行比较，观察手术时间和周围组织的损伤。

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. PUBLIC HEALTH RELEVANCE: Within the United States, approximately 70,000 deaf individuals have benefitted from cochlear implantation (CI), a 2+ hour surgery that involves removal of a portion of the bone behind the external ear to reach the inner ear, the cochlea, and place a wire which stimulates the cochlea allowing hearing. Using image guided surgical techniques-similar to GPS technology used to provide geographic directions-we have shown that a much less invasive surgical approach is possible by tracking and controlling the path of a drill such that the cochlea may be reached by a single drill pass-we call this technique Percutaneous Cochlear Implantation (PCI). After performing extensive research developing this technique, we have recently performed the world's first PCI and now propose to compare PCI to traditional CI surgery via a randomized clinical trial looking at time of surgery and injury of surrounding tissue.