Clinical Validation and Testing of Percutaneous Cochlear Implantation

经皮人工耳蜗植入的临床验证和测试

基本信息

批准号：
10595869
负责人：
ROBERT F LABADIE
金额：
$ 31.86万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-04-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10595869
关键词：
Acoustic Nerve Address Adopted Adoption Algorithms Anatomy Child Clinical Clinical Assessment Tool Clinical Research Clinical Trials Cochlea Cochlear Implants Cochlear duct Cochlear implant procedure Computer software Coupled Custom Development Devices Effectiveness Electrodes Excision Face Feasibility Studies Food Goals Grant Health Personnel Hearing Image Image-Guided Surgery Implant Individual Intervention Investigation Knowledge Labyrinth Labyrinthitis Manuals Medical Imaging Meningitis Modeling Nerve Nerve Endings Operative Surgical Procedures Osteogenesis Otolaryngologist Outcome Patients Performance Pharmaceutical Preparations Phase Postoperative Period Procedures Protocols documentation Research Safety Sensorineural Hearing Loss Societies Surface Surgeon System Techniques Technology Testing Time To specify Training Translating United States Validation Work World Health Organization X-Ray Computed Tomography base blind bone clinical translation clinically significant cost cost effective cost estimate cranium deaf design disability-adjusted life years economic impact efficacy evaluation hearing impairment image guided image processing improved innovation middle ear minimally invasive novel procedure cost public health relevance research clinical testing software development sound success surgery outcome tool

项目摘要

Project Summary/Abstract: The objective of this proposal is to perform a clinical feasibility study using our previously developed approach for minimally invasive cochlear implantation (CI), thereby bringing the approach closer to widespread clinical adoption. This translational work is the culmination of years of research and, if successful, will fundamentally change CI surgery and enable more patients to receive an implant. Clinical significance comes from the large number of patients who could benefit from a CI but have not received one, in part due to the complexity and invasiveness of the procedure. Despite their effectiveness, less than 10% of CI candidates have received an implant. The reasons for the underutilization include high procedure costs and a shortage of otolaryngologists trained to perform CI surgery. To bridge this gap, technological improvements to lower the cost of the procedure and make it easier to perform are necessary. Our approach to reduce the invasiveness and simplify the surgery uses image-guided surgery along with novel image processing algorithms. This approach replaces manual removal of a large volume of bone with a narrow drill path from the skull surface to the cochlea automatically aligned along the path using a patient-specific stereotactic frame. This approach may reduce the cost of the procedure and enable less specialized surgeons to perform the surgery. The technical and clinical innovations in this proposal include: (1) clinical translation of a novel surgical approach for which we have recently received an Investigation Device Exemption from the FDA, (2) multi- layered, redundant safety checks based on patient specific models and intra-operative hardware verification, (3) testing of an insertion tool with custom insertion depths based on patient specific anatomy, and (4) enabling individuals with ossified cochleae, a consequence of meningitis, to receive CI with this approach because current surgical techniques result in suboptimal electrode placement and performance in this group. Our approach consists of three Specific Aims. In Aim 1 we will complete an FDA approved clinical feasibility study using our minimally invasive technique comparing several key metrics between minimally invasive CI and traditional CI (electrode placement, audiological outcomes, and time of intervention). Aim 2 will further improve minimally-invasive CI through the development and testing of a custom CI insertion tool capable of inserting straight and pre-curved electrode arrays within the constrained workspace of the minimally invasive tunnel to the cochlea. We will perform a clinical assessment of the tool and compare insertions to those with traditional tools. In Aim 3 we will adapt the surgical approach to patients with ossified cochleae, a.k.a. labyrinthitis ossificans, a consequence of meningitis in which the cochlear duct becomes obstructed by new bone formation. To do this we will modify the minimally invasive technique to drill out multiple channels surrounding the auditory nerve endings and use post-operative imaging to specify how the electrodes stimulate the nerve.

项目摘要/摘要：该建议的目的是使用我们先前开发的方法进行临床可行性研究对于微创人工耳蜗（CI），从而使该方法更接近广泛的临床采用。这项翻译工作是多年研究的结晶，如果成功的话，将从根本上说明更改CI手术，并使更多的患者接受植入物。临床意义来自可从CI中受益但尚未收到的大量患者其中之一部分是由于该过程的复杂性和侵入性。尽管它们有效，但不到10％ CI候选人已收到植入物。未充分利用的原因包括高度程序成本以及缺乏接受CI手术的耳鼻喉科医生。弥合这一差距，技术需要改进以降低过程的成本并使其更容易执行。我们的方法降低侵入性并简化手术以及新的图像处理以及新的图像处理算法。这种方法用从使用患者特异性的立体定向框架自动沿着路径对齐的耳蜗表面。这方法可以降低手术的成本，并使较少的专业外科医生能够进行手术。该提案中的技术和临床创新包括：（1）新型手术的临床翻译我们最近收到了从FDA豁免的调查设备的方法，（2）多基于患者特定模型和术中硬件验证的分层冗余安全检查，（3）基于患者特定解剖结构的自定义插入深度的插入工具的测试，（4）启用脑膜炎的结果是骨性耳蜗的个人，以这种方法接受CI，因为当前的手术技术导致该组的次优电极位置和性能。我们的方法包括三个特定目标。在AIM 1中，我们将完成FDA批准的临床可行性使用我们的微创技术进行研究，比较微创CI和传统CI（电极放置，听力学结果和干预时间）。 AIM 2将进一步改善通过开发和测试能够插入的自定义CI插入工具的最小侵入性CI 在最小侵入性隧道的约束工作空间内的直曲线和预弯曲的电极阵列耳蜗。我们将对工具进行临床评估，并将插入与传统的插入进行比较工具。在AIM 3中，我们将适应骨口腔患者的手术方法，又称迷宫炎奥斯科人是脑膜炎的结果，其中人耳蜗被新骨形成阻塞。为此，我们将修改微创技术，以钻出围绕听觉的多个通道神经末端并使用术后成像来指定电极如何刺激神经。

项目成果

期刊论文数量（99）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Automatic localization of landmark sets in head CT images with regression forests for image registration initialization.

使用回归森林自动定位头部 CT 图像中的地标集，以进行图像配准初始化。

DOI：
10.1117/12.2216925
发表时间：
2016
期刊：
Proceedings of SPIE--the International Society for Optical Engineering
影响因子：
0
作者：
Zhang,Dongqing;Liu,Yuan;Noble,JackH;Dawant,BenoitM
通讯作者：
Dawant,BenoitM

Automatic segmentation of intracochlear anatomy in conventional CT.

DOI：
10.1109/tbme.2011.2160262
发表时间：
2011-09
期刊：
IEEE transactions on bio-medical engineering
影响因子：
0
作者：
Noble JH;Labadie RF;Majdani O;Dawant BM
通讯作者：
Dawant BM

Custom mastoid-fitting templates to improve cochlear implant electrode insertion trajectory.

DOI：
10.1007/s11548-020-02193-0
发表时间：
2020-10
期刊：
International journal of computer assisted radiology and surgery
影响因子：
3
作者：
Morrel WG;Riojas KE;Webster RJ 3rd;Noble JH;Labadie RF
通讯作者：
Labadie RF

Pre-operative Screening and Manual Drilling Strategies to Reduce the Risk of Thermal Injury During Minimally Invasive Cochlear Implantation Surgery.

DOI：
10.1007/s10439-017-1854-0
发表时间：
2017-09
期刊：
Annals of biomedical engineering
影响因子：
3.8
作者：
Dillon NP;Fichera L;Kesler K;Zuniga MG;Mitchell JE;Webster RJ 3rd;Labadie RF
通讯作者：
Labadie RF

Clinical validation study of percutaneous cochlear access using patient-customized microstereotactic frames.