NCT05079867Unknown不适用
Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Amplitude of cochlear microphonics
研究概览
简要总结
Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.
详细描述
Branches:
- Perimodiolar (PM)
- Lateral wall (PL)
Follow up schedule:
Preoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to receive a Cochlear implant 12 Months of age or older at the time of incorporation Willingness to participate and comply with the requirements of the protocol Residual hearing better than 80 dBA at 500 Hz
排除标准
- •Medical or pharmacological comorbid condition that contraindicates cochlear implantation.
- •Previous implantation in the ear of the new implant Ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide Abnormal cochlear / neural anatomy on preoperative CT or MRI (excluding dilated vestibular aqueduct syndrome) Deafness due to lesions of the central auditory pathway. (Exclusion for evaluation of residual hearing) Diagnosis of Auditory Neuropathy Spectrum Disorder (Exclusion for evaluation of residual hearing) Active infection in the middle ear Chronic inflammatory processes in the middle ear Disabilities that could prevent participation in the evaluations Unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol.
- •Surgical impossibility to follow the guidelines of the minimally traumatic technique.
结局指标
主要结局
Amplitude of cochlear microphonics
时间窗: 0-12 months
Postoperative amplitude of cochlear microphonics
次要结局
- Cochlear implant impedance(0-12 months)
- Residual hearing(0-12 months)
研究者
FEDERICO ALBERTO DI LELLA
MD PhD
Hospital Italiano de Buenos Aires
研究点 (1)
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