Nasal Obstruction Clinical Trial
Official title:
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
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.
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.
Animal tests have shown that TnR Nasal 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 long term safety and efficacy of
TnR Nasal Mesh as a material for nasal septoplasty.
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