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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 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.
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 (2)
Loading locations...
相似试验
已完成
不适用
Study of the ENTact Septal Staple System for Tissue Approximation During SeptoplastyNasal SeptumNCT00740480ENTrigue Surgical, Inc.25
已完成
不适用
Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma SubjectsPrimary Open Angle Glaucoma (POAG)NCT01252849Glaukos Corporation119
已完成
不适用
Straberi Epistamp Needling Treatment For Skin RejuvenationWrinkleElastic SkinCollagen DegenerationNCT04742803Universal Skincare Institute30
已完成
不适用
A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.Coronary Artery DiseaseIschemic Heart DiseaseNCT04475536Fundación EPIC501
终止
不适用
Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal FatMuscle StimulationAbdominal FatNCT05388617Cynosure, Inc.16