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临床试验/NCT03958006
NCT03958006已完成不适用

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Ascension South East Michigan2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
2
主要终点
Measurement of Hearing Parameters

研究概览

简要总结

This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

详细描述

This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection.

Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear

排除标准

  • 未提供

研究组 & 干预措施

Cochlear implantation

Experimental

Simultaneous cochlear implantation with tumor resection

干预措施: Cochlear implant (Device)

结局指标

主要结局

Measurement of Hearing Parameters

时间窗: 1 month, 3 months and 6 months postoperatively.

Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation.

次要结局

  • Measurement of Change of Physical Symptoms Associated with Hearing Loss(1, 3 and 6 months postoperatively)
  • Assessment of Change of Physical Symptoms Associated with Hearing Loss(1, 3 and 6 months postoperatively)
  • Assessment of incision site healing(1 week, and 1 and 3 months postoperatively)

研究者

发起方
Ascension South East Michigan
申办方类型
Other
责任方
Sponsor

研究点 (2)

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