What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- Number of weeks that ventilation tube lumen is patent.
研究概览
简要总结
Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.
详细描述
Institutional Review Board- Park Nicollet Institute approval was granted 3/2011 for 15 patients to be enrolled in pilot study of use of a bioabsorbable ventilation ear (PE) tube. IRB stated compliance with FDA as defined in 21 CFR, Part 56 and with regulations of DHHS. Federal assurance number FWA00000914. Prior to commencing this study, IRB approval was obtained and each participating clinician completed the NIH training for "Protecting Human Research Participants".
14 patients (15 ears) were enrolled in this study and were examined by 2 independent examiners at approximately 3, 6 and 12 week follow-ups. Lumen patency and time to complete resorption were documented by each examiner. There were no adverse reactions. This pilot study suggests that there is utility for a bioabsorbable ear tube made from gelatin material, as the device was found to break down over the expected time frame and remained functional long enough to have clinical utility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
2 examiners used otomicroscopy to document the function of the ear tube by documenting the number of weeks the lumen remained patent and the number of weeks until the device was fully resorbed. All examiners documented results independent of the other examiner.
入排标准
- 年龄范围
- 26 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)
排除标准
- 未提供
结局指标
主要结局
Number of weeks that ventilation tube lumen is patent.
时间窗: 0-3 months
Primary outcome was presence of a lumen, reflecting a functional device.
次要结局
- Number of weeks until ventilation tube is fully resorbed.(0-3 months)
研究者
Sandra Skovlund
Primary Investigator
Skovlund Medical Products, LLC