A Clinical Evaluation of the Safety and Performance of the Steroid-Releasing S8 Sinus Implant When Used in Post-Sinus Surgery Patients With Recurrent Sinus Polyps
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Sinuses With Successful Implant Delivery
研究概览
简要总结
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.
详细描述
The S8 PK study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. The S8 PK study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (MF) by measuring plasma MF and cortisol concentrations through 30 days post-procedure.
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
- •Diagnosis of chronic sinusitis
- •Prior bilateral total ethmoidectomy
- •Recurrent sinus obstruction due to polyps grade 2 or higher
排除标准
- •Required use of mometasone furoate within 2 weeks prior to implant procedure
- •Significant scarring or adhesions of the sinus
研究组 & 干预措施
S8 Sinus Implant
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
干预措施: S8 Sinus Implant (mometasone furoate, 1350 mcg) (Drug)
结局指标
主要结局
Number of Sinuses With Successful Implant Delivery
时间窗: End of baseline procedure
Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure
次要结局
- Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ(Days 3, 7, 14, 21 and 30)