A Multi-center, Non-randomized, Open, Single-arm Confirmatory Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty in Septal Deformity Patients With Nasal Obstruction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- NOSE total scores at 12 weeks after the surgery
研究概览
简要总结
The purpose of this clinical trial is to evaluate safety and efficacy of TnR mesh for patients who need nasal septoplasty for septal deformity with nasal obstruction.
详细描述
Nasal obstruction is a nasal disease commonly seen in the area of otolaryngology, and major symptoms include nasal congestion, rhinitis, and etc.
Nasal septoplasty is a surgery performed to improve above symptoms of nasal obstruction and so far, many surgical technique have been studied. All surgical techniques aimed to improve breathing through the nasal cavity by supporting the end of nose using surgical materials such as autologous bone or nonabsorbable material.
In the case of autologous bone transplantation, safety is ensured, but there is a limitation since it causes deficiency of the donor site, and the nasal septum may be altered by a modification of the implanted tissue.
In the case of nonabsorbable materials, there is a high risk of side effects such as hyposmia, septal perforation, and occurrence of boil.
TnR mesh, as a surgical material for nasal septoplasty has a sufficient flexural strength to support the nasal septum and to overcome the force of returning to a deviated state prior to surgery.
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
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with nasal septal deformity who require surgical treatment
- •Females of childbearing potential must have a negative urine pregnancy test, and must not plan to become pregnant during the course of the study.
排除标准
- •Known allergic reaction to medical devices(TnR mesh) of the clinical trial
- •Pregnancy or lactation
- •Before screening
- •History of surgery in nasal or paranasal sinuses before screening
- •History of radiation treatment at Head and neck
- •History of having participated in other clinical trial of a drug/ a medical device within three months
- •Screening point
- •Patients with untreated nasal bone fraction or trauma of nasal
- •Patients with surgical site infection caused by nasal bone fraction or trauma
- •Patients with untreated a perforation of septum, a sinusitis, a nasal cavity polyposis, a nasal cavity sarcoidosis, nasal valve collapse or wegener's granulomatosis
- •Patients with inflammation in a nasal cavity
- •Patients with sarcoma or carcinoma in a nasal cavity
- •Patients with asthma
- •Patients with untreated palate-facial disfigurements or cleft palate
- •Patients with systemic inflammatory disease
- •Patients with sepsis
结局指标
主要结局
NOSE total scores at 12 weeks after the surgery
时间窗: 12 weeks
The change in NOSE total scores of the 12th week after the surgery
次要结局
- NOSE score by topic(4 and 12 weeks)
- Acoustic rhinometry results(volume sum)(4 and 12 weeks)
- Level of satisfaction of patients(12 weeks)
- NOSE total scores(4 weeks)
- CT images(cross sectional area)(12 weeks)
- Acoustic rhinometry results(cross-sectional sum)(4 and 12 weeks)
- CT images(ratio of convex to concave side)(12 weeks)
- CT images(nasal septum angle)(12 weeks)
- Ratio of improvement regarding symptoms(12 weeks)