NCT03088618

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: T&R Biofab Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 74 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Septal Deformity
• Nasal Obstruction

Interventions

Type	Name	Description
PROCEDURE	Nasal septoplasty	Type of surgery

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2017-03-23
• Last updated: 2017-03-23

Locations

2 sites across 1 country: South Korea