Nasospore Stent For The Use in Endoscopic Sinus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Lahey Clinic
- 试验地点
- 1
- 主要终点
- This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution
研究概览
简要总结
The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.
详细描述
This study will compare other sinus stenting products to the Nasopore stent. The stents will be soaked in antibiotic solutions and be observed for how well they perform. Subjects will have a stent placed in each sinus, stents may be the standard antibiotic saturated materials or the new nasopore material or nasopore stent soaked in antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Evaluation by Otolaryngologist & determined to need endoscopic sinus surgery
- •Only subjects with Bilateral disease
排除标准
- •Pediatric subjects(under the age of 18)
研究组 & 干预措施
Merogel stent vs. Nasopore Stent
This study has two arms consiting of 50 subjects each (100 total) Arm 1 will recieve the standard stent (merogel)in their right sinus and a nasopore stent in their left sinus.
干预措施: Merogel Nasal Stent and Nasopore Stent (Drug)
bacitracin vs. gentamicin treated stent
The second arm will consist of 50 new subjects. These 50 subjects will have a nasopore stent placed in the left sinus. The first 25 subjects will have nasopore stent placed postoperatively with a bacitracin soaked nasopore in right sinus the second 25 will have a gentamycin soaked nasopore stent in right sinus.
干预措施: Merogel Nasal Stent and Nasopore Stent (Drug)
bacitracin vs. gentamicin treated stent
The second arm will consist of 50 new subjects. These 50 subjects will have a nasopore stent placed in the left sinus. The first 25 subjects will have nasopore stent placed postoperatively with a bacitracin soaked nasopore in right sinus the second 25 will have a gentamycin soaked nasopore stent in right sinus.
干预措施: Nasopore Stent and either Gentamycin or Bacitracin (Drug)
结局指标
主要结局
This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution
时间窗: prospective
次要结局
未报告次要终点