NCT03723161已完成不适用
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Stability 12 months
研究概览
简要总结
The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of using the system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have decided to undergo a Bone Anchored Hearing Surgery
- •Diagnosed with atresia
- •Signed informed consent
- •Patients between 2,5 - 18 years of age
- •Patients eligible for one stage surgery
排除标准
- •Not fluent in Swedish or English; subject and/or legal guardian
- •Unwillingness to participate in follow up visits
结局指标
主要结局
Stability 12 months
时间窗: 12 months post surgery
The development of implant stability during the first 12 months after implantation; as measured by difference in mean of (Implant Stability Quotient) ISQ low 12 months compared to surgery.
次要结局
- Implant survival rate(24 months post surgery)
- Performance audibility PTA4(1 month post surgery)
- Functional assessment(12 months, 24 months)
- Skin conditions Holger(7-10 days,12 months, 24 months post surgery)
- Stability 24 months(24 months post surgery)
- Performance speech intelligibility(1 month post surgery)
- Skin conditions IPS evaluation(7-10 days,12 months, 24 months post surgery)
- Performance audibility(1 month post surgery)
- Sustainability of audibility performance(1 month, 12 months, 24 months post surgey)
- Sustainability of audibility PTA4 performance(1 month, 12 months, 24 months post surgey)
- Sustainability of speech intelligibility performance(1 month, 12 months, 24 months post surgey)
研究者
研究点 (1)
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