Clinical Extend Study to Evaluate Safety and Effectiveness of TnR Nasal Mesh for Correction of Nasal Septum on Patients Who Need Correction of Nasal Septum That Accompanies With Rhinanchone Symptom
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Total NOSE score change after surgery compared to before surgery
研究概览
简要总结
The purpose of this observation study is to evaluate long term safety and efficacy at 2~3 years after surgery on patients who have completed nasal septal deformity surgery using TnR Nasal Mesh.
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 Nasal 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
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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 who have completed nasal septal deformity surgery using TnR Nasal Mesh.
- •Females of childbearing potential must have a negative urine pregnancy test, and must not plan to become pregnant during the course of the study.
- •A person who voluntarily signed a consent form after hearing and understanding the description of this clinical study.
排除标准
- •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 inflammation in a nasal cavity
- •Patients with asthma
- •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 sarcoma or carcinoma in a nasal cavity
- •Patients with untreated palate-facial disfigurements or cleft palate
- •Patients with sepsis
- •Patients with systemic inflammatory disease
- •Patients who are unsuitable for clinical sturdy determined by the researcher.
结局指标
主要结局
Total NOSE score change after surgery compared to before surgery
时间窗: 1 day
The descriptive statistics(population, mean, standard deviation, median, minimum, maximun value) are presented for total NOSE score change after surgery compared to before surgery. All measurement will be completed at the time of each patient's initial visit, 1 day Total NOSE score of before surgery is based on the results of previous clinical study. The NOSE(Nasal Obstruction Symptom Evaluation) score is a 5-step scale (0(asymptomatic)-4(very severe) points) of the severity of each symptom over the past month for the 5 symptoms related to nasal obstruction (nasal hyperemia / snagging / difficulty in breathing / sleeping disorder / difficulty breathing during exercise). Then, it is evaluated by interviewing patient. The total score of 20 points is converted to 100 points and recorded.
次要结局
- CT images(cross sectional area)(1 day)
- CT images(nasal septum angle)(1 day)
- NOSE score change(1 day)
- Acoustic rhinometry results(volume)(1 day)
- CT images(ratio of convex to concave side)(1 day)
- Acoustic rhinometry results(cross sectional area)(1 day)
- Level of satisfaction of patients using VAS(1 day)
- Ratio of improvement of regarding symptoms after surgery(1 day)