NCT06163404进行中（未招募）不适用
A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant for Correction of Cartilaginous Nasal Septal Deviation
适应症
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
- 102
- 试验地点
- 16
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
详细描述
To evaluate the safety and effectiveness of the Spirair Implant as a primary treatment for correction of cartilaginous nasal septal deviation.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥21 to ≤ 70 years of age at time of consent
- •Seeking treatment for nasal airway obstruction (NAO) symptoms due primarily to cartilaginous nasal septal deviation
- •Willing to undergo a nasal implant procedure
- •NOSE score ≥30 at Baseline Visit
- •Non-calcified, mobile cartilaginous nasal septal deviation
排除标准
- •Target nasal septal deviation that is calcified or non-mobile
- •Previous septoplasty or rhinoplasty
- •Having a concurrent ENT procedure, other than turbinate reduction
- •Saddle nose deformity
- •Congenital nasal defect
- •Documented evidence that middle meatus is not visualized on endoscopic exam due to severe septal deviation
- •Turbinate reduction within the past six (6) months
- •Permanent implant or dilator in the nose
- •History of nasal vasculitis, unhealed wounds, cartilaginous nasal septal perforation or mucosal irregularities
- •Active infection at the impllantation site e.g., folliculitis
- •Current or chronic systemic steroid and/or has had radiation exposure or active chemotherapy in the treatment area
- •Polyps or pathology, other than turbinate hypertrophy, that may be primary contributor to airway obstruction, in the opinion of the Investigator
- •History of a significant bleeding disorder(s) and or taking current prescription blood thinner medication
- •Hypersensitivity to any investigational device materials inclusing known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials
- •Major medical condition that could affect quality of life or wound healing and influence the results of the study (e.g., poorly controlled diabetes, HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
- •Active smoker or history of tobacco or tobacco-related product use within the past 1 year
- •Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
- •Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study
- •Currently participating, or plans to enroll in another clinical trial during this study or undergo another nasal septal treatment during study participation
- •History of non-compliance with medical treatment or clinical trial participation
- •Subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator determines the subject to be unable or unlikely to comply with protocol required follow-up
- •Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator
- •The subject is receiving prescription narcotic pain medication
- •The subject's condition represents a worker's compensation case
- •Symptoms of an upper respiratory infection e.g., runny nose, sneezing
- •History of untreated or inadequately controlled rhinitis (allergic and/or nonallergic)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 3 Months
Percent change in Nasal Obstruction Septoplasty Effectiveness scale (NOSE) improvement at Month 3 compared to baseline.
Primary Safety Endpoint
时间窗: 3 Months
Incidence of Serious Adverse Device Effects (SADEs), through Month 3.
次要结局
- Secondary Endpoint - 1(12 Months)
- Secondary Endpoint - 2(12 Months)
- Secondary Endpoint - 3(12 Months)
- Secondary Endpoint - 4(12 Months)
研究者
研究点 (16)
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