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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.

项目总结/文摘:

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）

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

DOI：
10.1097/mao.0b013e3181c2f81a
发表时间：
2010-01
期刊：
Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
影响因子：
0
作者：
Labadie RF;Balachandran R;Mitchell JE;Noble JH;Majdani O;Haynes DS;Bennett ML;Dawant BM;Fitzpatrick JM
通讯作者：
Fitzpatrick JM

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

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

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

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