The BONEBRIDGE in Children Below Five Years of Age Premarket Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Evaluation of speech intelligibility using the Göttinger Speech Intelligibility Test.
研究概览
简要总结
This study, titled "The BONEBRIDGE in Children Under Five: Premarket Clinical Investigation" (Study ID 2023BB006), looks at kids under five who have received the BONEBRIDGE BCI 602 hearing implant. This observational study, which is both retrospective (looking back) and prospective (looking forward), will take place at multiple hospitals. The main goal is to see if the BONEBRIDGE implant is safe for young children within 12 months after surgery.
Primary Goal: The study's main aim is to collect all information about any bad experiences or issues related to the device and the surgery to check its safety.
Secondary Goals:
Hearing Improvement: Using tests like the Göttinger Speech Intelligibility Test (Word Recognition Scores) to see how much the hearing improves with the implant.
Treatment History: Surgeons will fill out questionnaires about how the treatment went.
Quality of Life: Parents will answer questions about their child's quality of life using the GCBI questionnaire at least 12 months after the implant.
The study will last up to 12 months, including enrolling participants and performing all necessary procedures. The target number of participants includes at least 12 sets of data for safety checks and at least 5 sets of hearing performance data.
By collecting detailed information on any problems and assessing the performance of the BONEBRIDGE implant, this study aims to determine if it is safe and effective for young children.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Year 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who received the BONEBRIDGE BCI 602 implant before the age of five and have had the implant for at least 12 months.
- •Ability to perform the German language test. Willingness and ability to undergo all tests required by the study. Signed and dated informed consent obtained before any study-specific procedure and collection of retrospective data.
排除标准
- •Inability to perform audiological tests due to psychological, emotional, or related physical disorders.
- •Failure to meet any inclusion criteria. Any condition that, in the investigator's opinion, poses an increased risk to the patient or prevents full compliance or completion of the study.
结局指标
主要结局
Evaluation of speech intelligibility using the Göttinger Speech Intelligibility Test.
时间窗: Day 1
Hearing Improvement: determined by using the Göttinger Speech Intelligibility Test (Word Recognition Scores). Improvements in hearing with the BONEBRIDGE implant will be evaluated in device aided and unaided condition at least 12 months post-implantation.
次要结局
- Assessment of quality of life using the GCBI questionnaire(Day 1)
- Evaluation based on treatment history questionnaires for surgeons(Day 1)