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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Nasal Obstruction, Septal Deformity

Intervention / Treatment
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* Procedure: Nasal septoplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with septal deformity<br>To evaluate the safety and efficacy of surgical material for nasal septoplasty in septal deformity patients with nasal obstruction | Procedure: Nasal septoplasty<br>* Type of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NOSE total scores at 12 weeks after the surgery | The change in NOSE total scores of the 12th week after the surgery | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NOSE total scores | The change in NOSE total scores 4 weeks after the surgery | 4 weeks | 
| NOSE score by topic | NOSE score by topic 4, 12 weeks after the surgery | 4 and 12 weeks | 
| Acoustic rhinometry results(cross-sectional sum) | Changes in bilateral nasal cavity cross sectional sum in acoustic rhinometry results 4, 12 weeks after the surgery | 4 and 12 weeks | 
| Acoustic rhinometry results(volume sum) | Changes in bilateral nasal cavity volume sum in acoustic rhinometry results 4, 12 weeks after the surgery | 4 and 12 weeks | 
| CT images(cross sectional area) | Changes in nasal cavity cross-sectional area in CT images 12 weeks after the surgery | 12 weeks | 
| CT images(ratio of convex to concave side) | Changes in nasal cavity raio of convex to concave side of cross-sectional area in CT images 12 weeks after the surgery | 12 weeks | 
| CT images(nasal septum angle) | Changes in nasal septum angle in CT images 12 weeks after the surgery | 12 weeks | 
| Ratio of improvement regarding symptoms | Ratio of improvement regarding symptoms 12 weeks after surgery | 12 weeks | 
| Level of satisfaction of patients | Satisfaction score(used visual analogue scale) of subject 12 weeks after surgery | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal obstruction, Septal deformity, Septoplasty, TnR Mesh, polycaprolactone