NCT00957502已完成不适用
A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Clinical performance of aged ENTact™ Septal Staples
研究概览
简要总结
This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum.
- •Patient is able to provide a signed informed consent form.
- •Patient will agree to comply with all study related procedures.
- •Subject is not pregnant at this time by confirmation of one of the following:
- •subject is male,
- •subject not of child bearing age,
- •subject is surgically sterile,
- •subject is not pregnant per negative hCG test.
- •Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.
排除标准
- •Patients who have had previous septoplasty
- •Patients with uncontrolled diabetes
- •Presence of infection at the study site
- •Subject is a:
- •severe drug abuser,
- •severe alcohol abuser.
- •Patient with autoimmune disease deemed clinically significant by the Principal Investigator.
研究组 & 干预措施
One year aged staples
Experimental
Subjects implanted with sterile staples aged to approximately one year.
干预措施: ENTact™ Septal Stapler (Device)
18 month aged staples
Experimental
Subjects implanted with sterile staples aged to approximately 18 months.
干预措施: ENTact™ Septal Stapler (Device)
结局指标
主要结局
Clinical performance of aged ENTact™ Septal Staples
时间窗: One week post op
次要结局
- Clinical evaluation of gross tissue appearance at implantation site(s)(One week post op)
- ENTact™ Septal Staple functionality based on maintained coaptation(One week post op)
研究者
研究点 (1)
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