A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of TurbAlign™ to Achieve Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery (FESS) (GAIA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Spirair, Inc
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Miller Synechia Score
研究概览
简要总结
A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery
详细描述
To evaluate the safety and effectiveness of the Spirair implant as a primary treatment to achieve medialization of the middle turbinate after functional endoscopic sinus surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 to ≤ 75 years of age at time of consent
- •Subject scheduled to undergo bilateral endoscopic sinus surgery
- •Willing and able to provide informed consent and comply with the study protocol
排除标准
- •History of removal of one or both middle turbinates
- •Presence of significant concha bullosa, which requires surgical excision
- •Presence of non-viable tissue at the implantation site
- •Active infection at the implantation site
- •Chronic nasal decongestant use (i.e. Afrin, etc)
- •Recreational intra-nasal drug use within 12 months of enrollment
- •Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
- •Hypersensitivity to any investigational device materials including known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials
研究组 & 干预措施
Open-label
Treatment with the Spirair device as a treatment for medialization of the middle turbinates
干预措施: Implantation of Spirair device into the middle turbinates (Device)
Open-label
Treatment with the Spirair device as a treatment for medialization of the middle turbinates
干预措施: TurbAlign (Device)
结局指标
主要结局
Miller Synechia Score
时间窗: 8 Weeks
Rate of lateral synechia formation resulting in occlusion of the middle meatus at each turbinate (Miller Synechia Score of 2 or 3) observed at 8 weeks.
次要结局
- Inflammation assessment(8 weeks)
- Middle Turbinate Position Grade(4 and 8 weeks)
- Miller Synechia Score(4 weeks)