NCT01733667已完成不适用
A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Miller synechia score at 8 weeks
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.
详细描述
MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subject scheduled to undergo bilateral endoscopic sinus surgery
- •Subject signs IRB-approved informed consent form
- •Subject agrees to comply with all study-related procedures
排除标准
- •History of removal of one or both middle turbinates
- •Significant sinonasal polyps
- •Presence of marked septal asymmetry
- •Presence of significant concha bullosa, which requires surgical excision
- •Presence of non-viable tissue at the implantation site
- •Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's granulomatosis
- •Known or suspected allergy to device components
- •Participating in another clinical trial which could affect the healing of the middle turbinate
- •Uncontrolled diabetes
- •Known or suspected use of illicit drugs
- •Known or suspected alcoholism
- •Other medical illness that could prevent follow-up or increase the risk of surgery
- •Pregnant or unwilling to take pregnancy prevention measures
- •Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea
结局指标
主要结局
Miller synechia score at 8 weeks
时间窗: 8 weeks post endoscopic sinus surgery
Miller synechia score at 8 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 8 weeks judged by an independent evaluator)
次要结局
- Miller Score at 4 & 8 weeks(4 & 8 weeks post endoscopic sinus surgery)
研究者
研究点 (10)
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