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
- 1
- 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
- •Eligible participants are:
- •Adult patients seeking treatment for nasal obstruction on one or both sides of the nose who are willing to undergo an office-based or intraoperative nasal implant procedure in lieu of alternative treatments (ie, surgical repair or use of an external dilator).
- •Nasal valve collapse (NVC) must be a primary or significant contributor to the subject's nasal obstruction based on clinical presentation, physical examination and nasal endoscopy.
- •Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥
- •Participants are excluded for the following:
- •Surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months before enrollment.
- •Septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6 months before enrollment.
- •Recurrent nasal infections.
- •Use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation.
- •Presence of a permanent implant, dilator, or uses an external device in the nasal area.
- •Cancerous or precancerous lesions and/or radiation exposure in the treatment area or chemotherapy within 24 months of the study.
- •Significant bleeding disorders.
- •Significant systemic diseases.
- •Currently using nasal oxygen or continuous positive airway pressure (CPAP).
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 (1)
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