Balloon REmodeling Antrostomy THErapy Study (BREATHE I)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 26
- 主要终点
- Patency of the Treated Area as Verified by CT Scan
研究概览
简要总结
This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects age 18 or older with chronic rhinosinusitis of the maxillary or maxillary and anterior ethmoid sinuses
- •A CT scan taken after maximal medical therapy (e.g., local or systemic antibiotics, topical steroids, etc.) must show one of the following:
- •Narrowing of the outflow tract of the maxillary sinus ostium or infundibulum with mucosal thickening of 2 mm or greater of the maxillary sinus antrum.
- •Evidence of maxillary sinus air/liquid level.
排除标准
- •Evidence of chronic posterior ethmoid, sphenoid or frontal sinusitis
- •Inability to understand the study or a history of non-compliance with medical advice
- •Unwilling or unable to sign Informed Consent Form (ICF)
- •Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies)
- •History of any cognitive or mental health status that would interfere with study participation
- •Previous sinus surgery or intervention including sinuplasty
- •Pregnant women
- •Severe septal deviation causing obstruction of the ostiomeatal unit
- •History of primary ciliary dysfunction
- •Hemophilia
- •Currently undergoing or in the past 6 months had undergone chemotherapy for cancer or radiation therapy in the head or neck region
- •History of cystic fibrosis
- •Known Sampter's Triad (aspirin sensitivity, asthma, sinonasal polyposis)
- •Known sinonasal tumors or obstructive lesions
- •History of mid facial fractures or orthognathic surgery (does not include nasal fracture)
- •History of insulin dependent diabetes
- •Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio(INR) is below 1.5
- •Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure
- •Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure
- •Presence of nasal polyps that may interfere with the treatment procedure
- •Presence of features consistent with sinus fungal disease on CT or physical examination
研究组 & 干预措施
Balloon Dilation
Balloon dilation with FinESS device
干预措施: RS-Series Rhinosinusitis Treatment System (Device)
Balloon Dilation
Balloon dilation with FinESS device
干预措施: FinESS Balloon (Device)
结局指标
主要结局
Patency of the Treated Area as Verified by CT Scan
时间窗: Post-treatment at 3 months
Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.
Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement
时间窗: Post-treatment through 12 months
Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful.
Incidences of Device-related or Procedure-related Complications
时间窗: Through 12 months post-procedure
次要结局
未报告次要终点