A Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty

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

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.

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. Animal tests have shown that TnR mesh well supports the nasal septum after surgery and the surrounding tissue is well fused between the pores without inflammatory responses. Based on above results, a clinical trial was planned to evaluate the efficacy and safety of TnR mesh as a material for nasal septoplasty.

To evaluate the safety and efficacy of surgical material for nasal septoplasty in septal deformity patients with nasal obstruction

Changes in bilateral nasal cavity cross sectional sum in acoustic rhinometry results 4, 12 weeks after the surgery

Changes in bilateral nasal cavity volume sum in acoustic rhinometry results 4, 12 weeks after the surgery

Changes in nasal cavity raio of convex to concave side of cross-sectional area in CT images 12 weeks after the surgery

A follow-up will be performed after the surgery until the end of the clinical trial period. Any newly occurred or worsen symptoms will be recorded. Preparation content: Deviant-cases name, expression date, disappearance date, severity, gravity, results, a relationship between a medical device, a treatment, a status(remove or not). All deviant-cases are standardized as System Organ Class (SOC) and Preferred Term (PT) according to Medical Dictionary for regulatory activities (MedDRA). The analysis of deviant-case is based on the Treatment Emergent Adverse Event (TEAE). The percentage and the number of deviant cases and abnormal reactions to the device will be proposed as well as the 95 % of confidence interval of the incidence.

Inclusion Criteria: 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. Exclusion Criteria: 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

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