NCT00896883已完成不适用
A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Functional performance of the MTI
研究概览
简要总结
The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Principal Investigator determines clinical relevance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery.
- •Subject is able to provide a signed informed consent form.
- •Subject will agree to comply with all study-related procedures.
- •Subject is not pregnant at this time by confirmation of one of the following:
- •Subject is male
- •Subject not of child bearing age
- •Subject is surgically sterile
- •Subject is not pregnant per negative hCG test
- •Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.
排除标准
- •Subject does not meet inclusion criteria.
- •Presence of non-viable tissue at the implantation site.
- •History of septal perforation.
- •History of polyps.
- •Presence of concha bullosa.
- •Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea.
- •Subject is participating in a clinical trial which could affect the healing of the middle turbinate.
- •Subject has uncontrolled diabetes.
- •Subject is a:
- •severe drug abuser
- •severe alcohol abuser
- •Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.
结局指标
主要结局
Functional performance of the MTI
时间窗: 1 month
次要结局
- Visual tissue reaction to the Middle Turbinate Implant(1 month)
研究者
研究点 (8)
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