Nasal Obstruction Clinical Trial
Official title:
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.
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