XprESS Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Safety Assessments
研究概览
简要总结
This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).
详细描述
Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients.
One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.
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
- •18 years of age or older
- •Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
- •Willing and able to provide consent
排除标准
- •Known Samter's Triad
- •History of primary ciliary dysfunction
- •History of cystic fibrosis
- •Known to be immunosuppressed
- •Hemophilia
- •Currently enrolled in another pre-approval investigational study
结局指标
主要结局
Safety Assessments
时间窗: 1 month after procedure
Adverse event reporting as related to XprESS device or procedure
次要结局
- Sino-Nasal Outcome Test (SNOT-20) at 1 Month(Baseline and 1 month after procedure)
- SNOT-20 at 6 Months(Baseline and 6 months post procedure)
- SNOT-20 at 12 Months(Baseline and 12 months post procedure)