Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.
研究概览
简要总结
Study Design:
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects age 17 years or older
- •Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)
- •Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)
排除标准
- •Age < 17 years old
- •History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP >21 mmHg)
- •Adequate anatomical distances for treatment
- •Patient received oral steroid treatment within two weeks prior to day of surgery
- •Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement
- •Sinonasal tumors or obstructive lesions
- •History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus
- •Contracted/underdeveloped ethmoid sinus
- •Dehiscent lamina orbitalis
- •Previous ethmoid surgery
- •Ethmoid mucocele
- •Extensive Nasal Polyps
- •Asthmatic patients with aspirin sensitivity
- •Pregnant or lactating females
结局指标
主要结局
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.
时间窗: 10 weeks post-procedure
The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.
次要结局
- Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg(10 weeks post-procedure)
- Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)(10 weeks post surgery)
- Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline(10 weeks)