Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in SNOT-20 Score
研究概览
简要总结
The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.
详细描述
This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).
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
- •Be at least age 18 years old or older.
- •Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.
- •Have a sinus CT scan within 12 months of the procedure date.
- •Be able and willing to provide consent.
- •Be willing to comply with the protocol requirements.
排除标准
- •Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
- •Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
- •Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
- •Have presence of features consistent with sinus fungal disease.
- •Be allergic to nickel or barium sulfate.
- •Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.
结局指标
主要结局
Change in SNOT-20 Score
时间窗: Baseline and 1-year post procedure
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.
次要结局
- Number of Participants With Serious Device and/or Procedure-related Adverse Events(Through 1-year post procedure follow-up)
- Revision Sinus Surgery(1-year post procedure)