跳至主要内容
临床试验/NL-OMON48826
NL-OMON48826
已完成
不适用

Association Between Intra-Operative Cochlear Response Telemetry and Hearing Preservation. - CREST study

Cochlear Ltd0 个研究点目标入组 15 人待定

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
cochlear monitoring
发起方
Cochlear Ltd
入组人数
15
状态
已完成
最后更新
2年前

概览

简要总结

Trial ended prematurely

注册库
who.int
开始日期
待定
结束日期
2020年5月1日
最后更新
2年前
研究类型
Observational invasive

研究者

发起方
Cochlear Ltd

入排标准

入选标准

  • \* Candidate for cochlear implantation according to local indications
  • \* 18 years of age or older at the time of enrolment
  • \* Pre\-operative audiometric threshold in the implanted ear at 500 Hz of better
  • than or equal to 80 dB HL
  • \* Willingness to participate in and to comply with all requirements of the

排除标准

  • \* Prior cochlear implantation in the ear to be implanted
  • \* Ossification or any other cochlear anomaly that might prevent complete
  • insertion of the electrode array
  • \* Abnormal cochlear/nerve anatomy on pre\-operative CT or MRI imaging (excluding
  • a mild Mondini malformation or Large Vestibular Aqueduct Syndrome)
  • \* Deafness due to lesions of the acoustic nerve or central auditory pathway
  • \* Diagnosis of auditory neuropathy
  • \* Active middle\-ear infection
  • \* Additional handicaps that would prevent participation in evaluations
  • \* Unrealistic expectations on the part of the subject, regarding the possible

结局指标

主要结局

未指定

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