Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 8
- 主要终点
- Intraoperative complications at surgery
研究概览
简要总结
This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.
详细描述
The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor.
The study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards
- •Signed informed consent (applicable for subjects answering questionnaires)
排除标准
- •No exclusion criteria have been set for this observational investigation
结局指标
主要结局
Intraoperative complications at surgery
时间窗: During the Ponto-implantation surgery
次要结局
- To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire(3 months after surgery)
- To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI)(3 months after surgery)
- Assessment of procedure room variables(12 months after study start)
- To assess surgical parameters(During Ponto-implantation surgery)
- Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire(5-10 days after Ponto surgery)
- To assess postoperative events and complications(From day of surgery, through study completion, an average of 1 year)
- To assess rate of implant survival(3 months after surgery, and through study completion, an average of 1 year.)
- To assess time from surgery to sound processor loading(Time from surgery to sound processor loading which happens at an average of 3 months after surgery.)
- To assess sound processor usage time(3 months after surgery, and through study completion, an average of 1 year.)