NCT02188589已完成不适用
Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Spirox, Inc.
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Implant-related Adverse Events
研究概览
简要总结
To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
详细描述
This study is a multicenter, nonrandomized, prospective exploratory study of the INEX Nasal Implant. The purpose of this study is to evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nasal implant group
Experimental
Bilateral or unilateral INEX nasal implants
干预措施: INEX nasal implant (Device)
结局指标
主要结局
Implant-related Adverse Events
时间窗: 6 months
Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)
次要结局
- Breathing Capacity (NOSE Scores)(At baseline and at 6, 12, and 24 months post implant)
- NOSE Responder Rate(At 6, 12, and 24 months post implant)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Validity Study of a Nasal Valve ImplantNasal Valve CollapseNCT00837525Nasoform, LLC4
已完成
1 期
Evaluation of Corfluvec Vaccine for the Prevention of COVID-19 in Healthy VolunteersCOVID-19NCT05696067Tatyana Zubkova200
已完成
不适用
Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base SurgerySkull Base NeoplasmsSkull NeoplasmsBone NeoplasmNeoplasmsBone DiseasesMusculoskeletal DiseaseNCT03072186Ohio State University23
已完成
1 期
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics of HS-10345 In Treatment-Resistant DepressionTreatment Resistant Depressive DisorderNCT05196971Jiangsu Hansoh Pharmaceutical Co., Ltd.12
已完成
不适用
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS)Sjogren SyndromeNCT06626477Abilion Medical Systems AB26