Efficacy of the ArchSinus, NasoPore and the Propel Stent in Preventing Post-Surgical Middle Turbinate Lateralization and Improving the Symptomatic Outcomes; Randomized, Blinded, Comparative Study
试验速览
- 阶段
- 不适用
- 发起方
- STS Medical
- 入组人数
- 50
- 主要终点
- Middle turbinate lateralization 12 week post FESS (based CT scan)
研究概览
简要总结
This is a multi-center, randomized, single-blinded comparative 3-arm clinical study. This clinical study is designed to compare the efficacy of the ArchSinus stent to the Propel stent (Intersect ENT), and to NasoPore (Stryker) in preventing post-FESS middle turbinate lateralization 3 weeks, 6 weeks, 3 months and 12 months post FESS.
详细描述
50 chronic rhinosinusitis patients, that met the inclusion criteria will undergo bilateral FESS and subsequent bilateral placement of the ArchSinus into the randomized ethmoid sinus cavity and NasoPore / Propel into the other ethmoid sinus cavity. Comparative treatment sides will be randomly assigned; 50 sinuses treated with ArchSinus stent, 25 sinus treated with Propel stent, 25 sinuses treated with Nasopore. Standard Propel implant and 4cm whole NasoPore will be used.
ArchSinus stent will be removed 2 weeks (13-15 days) post FESS. Propel will be removed as necessary 2 weeks (13-15 days) post FESS. NasoPore arm will be debrided as necessary 2 weeks (13-15 days) post-FESS. Prior to removal / debridement procedures, the patients will be blindfolded, to keep them blinded for the treatment type on each side of their nose.
All patients will be followed up at 2, 6 and 12 weeks and 12 months post FESS and examined endoscopically. The endoscopic videos will be analyzed by independent pannel of 3 ENT surgeons, blinded to the treatment type, to assess middle turbinate lateralization on a 4-point scale.
CT scan will be performed pre-FESS and 12 weeks after the operation, to assess middle turbinate lateralization, as demonstrated by percent change in middle meatus (MM) area pre-FESS and 12 weeks after the surgery. Inflammatory mucosal thickening will be quantified using the Zinreich staging system. CT scans will be analyzed blindly by Medical Metrics Inc.
Symptomatic improvement will be analyzed weekly within 3 months follow up, using Side-specific Nasal SNOT-22 questioner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Primary objective will be analyzed using nasal video endoscopy and a CT scan, by an external experts in a blinded fashion. Secondary objective will be analyzed using side-specific SNOT-22 questioner, subjects will be blinded to the treatment type.
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
- •Diagnosis of chronic rhinosinusitis defined as symptomatic inflammation of the sinuses of at least 12 consecutive weeks duration despite medical management
- •CT scan examination with a minimum Zinreich score of 5 prior to study entry
- •Less than 2-point Zinreich score difference between two sides
- •Primary FESS including bilateral total ethmoidectomy; symmetrical uncinate process reduction
排除标准
- •Inferior turbinectomy, reduction or outfracture
- •Polyp grade ˃ 4 bilaterally on Lildholdt's scale (1-3)
- •Concha bullosa
- •Severe nasal septal deviation at the level of OMC
- •Sinonasal tumors
- •FESS including asymmetrical resection of the middle turbinate
- •Known allergy to nickel
- •Known polyurethane induced dermatitis
- •Oral steroid-dependent condition
- •Momometasone furoate intolerance
- •Known hypersensitivity to lactide, glycolide or caprolactone copolymers.
- •Glaucoma or cataract
- •History of immune deficiency
- •Cystic fibrosis
- •Pregnant or lactating female
- •Acute sinus inflammation
- •Coagulation disorders
结局指标
主要结局
Middle turbinate lateralization 12 week post FESS (based CT scan)
时间窗: 12 weeks post FESS
The primary objective is to compare the efficacy of the ArchSinus to Propel stent (Intersect ENT), to prevent post-FESS middle turbinate lateralization, 12 weeks post-FESS, based on CT scan.
次要结局
- Symptomatic outcomes within the 3-month post-FESS(12 weeks post FESS)
- Middle turbinate lateralization 12 week post FESS (based video endoscopy)(12 weeks post FESS)