iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Safety related to adverse events
研究概览
简要总结
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
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
- 9 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Candidate for unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices
- •Age 9 months to less than 12 years old at the time of CI surgery
- •Willingness to participate in the study and able to comply with the follow-up visit requirements
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 or present an increased risk of aberrant insertion
- •Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations
- •Deafness due to lesions of the acoustic nerve or central auditory pathway
- •Diagnosis of auditory neuropathy.
- •Active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease
- •Absence of cochlear development
- •Additional medical concerns that would prevent participation in evaluations as determined by the investigator
- •Planned or current participation in a clinical study of an investigational device or drug
研究组 & 干预措施
Pediatric Cochlear Implant Recipient
Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age who meet prescribed inclusion and exclusion criteria per protocol, signing and Informed Consent and completing active study period; enrollment through 30 days post cochlear implant surgery/activation per investigator site standard of care
干预措施: iotaSOFT Insertion System (Device)
结局指标
主要结局
Safety related to adverse events
时间窗: 30 days following surgery
Evaluation of iotaSOFT related adverse events and serious adverse events through 30 days after surgery
iotaSOFT Related-serious Adverse Events Measured by Calculating the Proportion of Subjects With One or More SAEs.
时间窗: (SAEs) through 30 days after CI surgery/activation
The primary endpoint of the study was to demonstrate safety of the iotaSOFT Insertion System through evaluation of iotaSOFT related serious adverse events through 30 days after CI surgery/activation.
次要结局
未报告次要终点