NCT05967169已完成不适用
Early Feasibility Study of Bioabsorbable Polydioxanone Implant and Delivery Device for Correction of Cartilaginous Septal Deviation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Spirair, Inc
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes
研究概览
简要总结
Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation
详细描述
To obtain safety, device performance, patient tolerability and effectiveness outcome data in participants with cartilaginous septal deviations undergoing placement of the Spirair Implant with the Spirair delivery device.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-calcified, mobile cartilaginous septal deviation.
- •≥21 years of age.
- •Willing and able to provide informed consent and comply with the study protocol.
- •Seeking treatment for nasal airway obstruction (NAO) due to septal deviation and is willing to undergo a nasal implant procedure.
- •Type I, II, or III septal deviation as defined by 7-Degree Mladina classification scheme
- •NOSE score ≥30 at Screening Visit.
- •Appropriate nasal anatomy to receive the implant(s).
排除标准
- •Type IV, V, VI or VII septal deviation as defined by 7-Degree Mladina classification scheme (See Table 2) or other non-cartilaginous septum anatomical pathology identified on CT scan suspected by Investigator to be the primary contributor to NAO.
- •Having a concurrent ENT procedure, other than turbinate reduction.
- •Previous septoplasty or rhinoplasty.
- •Has had turbinate reduction or other nasal surgeries within the past six (6) months.
- •Plans to have any surgical or non-surgical treatment of their nasal septum, other than the index procedure, within six (6) months of the procedure.
- •Permanent implant or dilator in the nasal area.
- •Concomitant autoimmune, inflammatory, or infectious skin conditions, unhealed wounds, septal perforation, or mucosal irregularities in the treatment area.
- •Currently has active nasal vestibulitis or folliculitis.
- •History of nasal vasculitis.
- •Current or chronic systemic steroid and/or recreational intra-nasal drug user.
- •Has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or active chemotherapy.
- •Polyps or pathology, other than turbinate hypertrophy, that may be primary contributor to airway obstruction, in the opinion of the investigator.
- •History of a significant bleeding disorder(s) and/or current prescription blood thinner medication that would prevent healing of the treatment area post procedure.
- •Known or suspected allergy to polydioxanone or other absorbable materials.
- •Significant systemic disease such as poorly controlled diabetes or connective tissue disease which, in the investigator's opinion, could pre-dispose the participant to poor wound healing.
- •Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day).
- •Female participants of childbearing potential who are known or suspected to be pregnant and/or lactating.
- •Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or increase risk.
- •Additionally, for OR cases (Cohorts 1 or 3) any individual who meets the following criteria will be ineligible for enrollment as an OR case
- •Is not a candidate for procedures conducted under general anesthesia.
- •Additionally, for in-office cases (Cohort 2) any individual who meets the following criteria will be ineligible for enrollment as an in-office case:
- •s not a candidate for procedures conducted under local anesthesia alone.
结局指标
主要结局
Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes
时间窗: 24 months
Feasibility of implantation and durability of Implant through the healing process
次要结局
未报告次要终点
研究者
研究点 (2)
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