jRCTs032230528招募中不适用
Exploratory Research for Dexamethasone-Eluting Cochlear Implant Electrode (CIDEX)
未提供0 个研究点目标入组 1 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1
- 主要终点
- change in mean/median speech perception outcome as % correct of speech test in quiet (Japanese Monosyllable test: iCI2004)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •General criteria
- •(1) Patient agreed to participate in the study and signed to the informed consent document.
- •(2) Age of 18 years or older when agreed.
- •(3) General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study and realistic expectations, as deemed appropriate by the implanting surgeon.
- •Medical criteria
- •(1) Post-lingual hearing loss.
- •(2) The pure tone average of affected side was below:
- •Equal to 85dB HL or below at 125Hz
- •Equal to 90dB HL or below at 250Hz
- •Equal to 60dB HL or over at 2000Hz - 8000Hz
- •(3) Evidence of functional auditory nerve in the ear to be implanted.
- •(4) Subject report of having used an optimally fit hearing aids for a minimum of three months before deciding that a cochlear implant is the preferential option.
- •(5) Cochlear anatomy compatible with the insertion of a FLEX28 electrode array.
排除标准
- •(1) Evidence of ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or might cause an increased risk of infection (e.g., dysplastic cochlea), as confirmed by medical examination and/or as per CT/MRT (Computed Tomography/Magnetic Resonance Tomography).
- •(2) Evidence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull.
- •(3) Known allergic reaction or intolerance to the materials used in the implant.
- •(4) Known absence of cochlear development or if the cause of deafness is non-functionality of the auditory nerve and/or the upper auditory pathway.
- •(5) Evidence of active external or middle ear infection or history of recurrent middle ear infection in the ear to be implanted.
- •(6) Evidence of perforated tympanic membrane in the ear to be implanted.
- •(7) Patient reporting immunosuppressive therapy or corticosteroids therapy in the 4 weeks before enrolment.
- •(8) Evidence of concomitant use of medicinal substances that could alter the therapeutic efficacy of dexamethasone.
- •(9) Unwillingness or inability of the candidate to comply with all investigational requirements.
- •(10) Evidence of medical contraindications to surgery of the middle and inner ear and anaesthesia.
- •(11) Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation.
结局指标
主要结局
change in mean/median speech perception outcome as % correct of speech test in quiet (Japanese Monosyllable test: iCI2004)
时间窗: from prior to implantation to 7 months post-implantation
Clinical performance of the Mi1250 SYNCHRONY 2 FLEX28 DEX: change in mean/median speech perception outcome as % correct of speech test in quiet (Japanese Monosyllable test: iCI2004) from prior to implantation to 7 months post-implantation with the Mi1250 SYNCHRONY 2 FLEX28 DEX. *iCI2004 test: Nishio et al., Acta Otolaryngol. 2021;141(3):267-272.
次要结局
未报告次要终点
研究者
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