NCT00740480已完成不适用
A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact Septal Staple System for Tissue Approximation During Septoplasties
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Coaptation (Tissue Approximation)
研究概览
简要总结
The purpose of this research study is to learn more about the ENTact™ Septal Staple System device performance and to collect information to support its premarket application.
详细描述
The ENTact™ Staple System is a device that inserts a small staple or tack to hold mucosa (moist tissues) in place instead of using stitches. The staple gradually dissolves and does not need to be removed. This clinical study will evaluate:
- surgical performance of the ENTact Septal Staple System
- one week post op clinical evaluation of gross tissue appearance at implantation site(s)
- ENTact™ Septal Staple functionality based on maintained coaptation
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 是
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
- •Patient is not pregnant at this time. If patient is of child-bearing age and capable of bearing children, a pre-operative pregnancy test confirmation is required to show that patient is not pregnant on the day of surgery
- •Patient does not plan on becoming pregnant and is not breast feeding during the course of the study
排除标准
- •Patients who do not meet the inclusion criteria
- •Patients who have had previous septoplasty
- •Patients with uncontrolled diabetes
- •Presence of infection at the site
- •Smokers and severe drug and alcohol abusers
- •Patients with autoimmune disease deemed clinically significant by Principal Investigator
结局指标
主要结局
Coaptation (Tissue Approximation)
时间窗: One week post surgery
Complete tissue approximation at one week.
次要结局
- Tissue Reaction to Implant(One week post surgery)
研究者
研究点 (3)
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