Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- STS Medical
- 入组人数
- 4
- 主要终点
- Sinus airflow and particle deposition rate
研究概览
简要总结
This is a single-center, single-arm, interventional case study designed to compare the sinonasal airflow and symptomatic status of four (4) chronic sinusitis patients, before and after the ArchSinus stent implantation.
详细描述
This is a single-center, single-arm, interventional case study. This case study is designed to compare the sinonasal airflow and symptomatic status of four (4) chronic sinusitis patients who after undergoing primary FESS were seen to have symptomatic lateralization of the middle turbinate and underwent medialization of the middle turbinate accompanied by ArchSinus stent implantation.
Patient eligibility will be confirmed based on the endoscopic examination and SNOT-22 score.
Patient history will be taken, specifically which if any nasal spacer was used after the primary FESS.
4 chronic sinusitis patients that suffer from middle turbinate lateralization and symptomatic deterioration, 3-6 months after primary FESS, that met the inclusion / exclusion criteria, will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation. The stents will be removed 2-3 weeks after procedure.
CT scan will be performed at baseline and 12 weeks after the ArchSinus stent removal, and 3D sinonasal airways reconstruction of the maxillary, ethmoid, sphenoid & frontal sinuses will be performed. Subsequently, airflow and particle deposition will be simulated in each reconstruction, and airflow rate and particle deposition will be quantified for different sinuses.
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
- •Male/female, 18 year or older
- •Diagnosis of chronic rhinosinusitis defined as symptomatic inflammation of the sinuses of at least 12 consecutive weeks duration despite medical management
- •≥ 3 months post primary FESS
- •Symptoms of chronic rhinosinusitis defined as ≥ 10 score on SNOT-22
- •Middle turbinate lateralization defined as ˃ 2 score on MT lateralization scale
排除标准
- •Polyp grade ˃ 4 bilaterally on Lildholdt's scale (1-3)
- •Sinonasal tumors
- •Known allergy to nickel
- •Known polyurethane induced dermatitis
- •History of immune deficiency
- •Cystic fibrosis
- •Pregnant or lactating female
- •Acute sinus inflammation
- •Coagulation disorders
研究组 & 干预措施
ArchSinus implantation
Subjects will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation
干预措施: ArchSinus implantation (Device)
结局指标
主要结局
Sinus airflow and particle deposition rate
时间窗: 12 weeks
The primary objective of this study aims to compare the sinonasal airflow rate and particle deposition rate at Baseline and 12 weeks after the ArchSinus stent implantation, based on CFD analysis.
次要结局
- Symptomatic improvement(12 weeks)