NCT02952313已完成不适用
Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Spirox, Inc.
- 入组人数
- 113
- 试验地点
- 23
- 主要终点
- The Primary Efficacy Endpoint is the Percent of Treatment Responders
研究概览
简要总结
This study is being conducted to obtain outcomes data in subjects with severe to extreme class NOSE scores undergoing placement of the Spirox Latera Implant with or without concurrent septoplasty and/or turbinate reduction procedures in an operating room setting.
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
- •The subject has Nasal Obstruction Symptom Evaluation (NOSE) Score ≥
- •The subject has dynamic lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver
- •The subject is ≥18 years of age.
- •The subject is willing and able to provide informed consent and comply with the study protocol.
- •The subject is seeking treatment for nasal airway obstruction due to Nasal Valve Collapse (NVC) and is willing to undergo nasal Implant procedure alone or with septoplasty and/or a turbinate reduction procedure in an operating room setting.
- •The subject has appropriate nasal and facial anatomy to receive Latera Implant.
- •The subject agrees to follow-up examinations through twelve (12) months post operatively.
- •The subject has failed a trial of appropriate maximal medical management [e.g., nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones]. Failure of maximal medical management may be from lack of effectiveness or inability of subject to tolerate.
排除标准
- •The subject is having a concurrent Functional Endoscopic Sinus Surgery (FESS) or sinuplasty.
- •The subject has had rhinoplasty within the past twelve (12) months.
- •The subject is planning to have other concurrent rhinoplasty procedure.
- •The subject is planning to have other rhinoplasty procedures or will use external dilators within twelve (12) months after the index procedure.
- •The subject has had septoplasty and/or inferior turbinate reduction within the past six (6) months.
- •The subject has, in the view of the clinician, inappropriate fixation on their nasal airway.
- •The subject plans to have any surgical or non-surgical treatment of their nasal valve, other than the index procedure, within twelve (12) months of the study.
- •The subject has a permanent Implant or dilator in the nasal area.
- •The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.
- •The subject currently has active nasal vestibulitis.
- •The subject has a history of nasal vasculitis.
- •The subject is a chronic systemic steroid or recreational intra-nasal drug user.
- •The subject has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
- •The subject has polyps or pathology other than septal deviation and/or turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction.
- •The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.
- •The subject has a known or suspected allergy to poly lactic acid (PLA) or other absorbable materials.
- •The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could pre-dispose the subject to poor wound healing.
- •The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
- •The subject is not a candidate for procedures conducted under general anesthesia, managed anesthesia care (MAC) or conscious sedation.
- •If female, subject is known or suspected to be pregnant or is lactating.
结局指标
主要结局
The Primary Efficacy Endpoint is the Percent of Treatment Responders
时间窗: 6 months post procedure
Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events
时间窗: 6 months post procedure
Number of participants with a device-related or procedure-related adverse event
次要结局
- Percent of Treatment Responders(1, 3 12, 18, and 24 months post procedure.)
- Subject Satisfaction Questionnaire(6 months)
- Procedure and Device Related Adverse Events(After 6 months and up to 24 months post procedure)
- Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).(1, 3, 6, 12, 18, and 24 months post procedure)
研究者
研究点 (23)
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