Clinical Extend Study to Evaluate Safety and Effectiveness of TnR Nasal Mesh for Correction of Nasal Septum on Patients

Sponsor

T&R Biofab Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04332575

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Septal Deformity 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 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

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

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Outcome Measures

Primary Outcome Measures

Total NOSE score change after surgery compared to before surgery [1 day]
The descriptive statistics(population, mean, standard deviation, median, minimum, maximun value) are presented for total NOSE score change after surgery compared to before surgery. All measurement will be completed at the time of each patient's initial visit, 1 day Total NOSE score of before surgery is based on the results of previous clinical study. The NOSE(Nasal Obstruction Symptom Evaluation) score is a 5-step scale (0(asymptomatic)-4(very severe) points) of the severity of each symptom over the past month for the 5 symptoms related to nasal obstruction (nasal hyperemia / snagging / difficulty in breathing / sleeping disorder / difficulty breathing during exercise). Then, it is evaluated by interviewing patient. The total score of 20 points is converted to 100 points and recorded.

Secondary Outcome Measures

NOSE score change [1 day]
NOSE score change for each item after surgery compared to before. All measurement will be completed at the time of each patient's initial visit, 1 day The NOSE(Nasal Obstruction Symptom Evaluation) score is a 5-step scale (0(asymptomatic)-4(very severe) points) of the severity of each symptom over the past month for the 5 symptoms related to nasal obstruction (nasal hyperemia / snagging / difficulty in breathing / sleeping disorder / difficulty breathing during exercise). Then, it is evaluated by interviewing the patient. The total score of 20 points is converted to 100 points and recorded.
Acoustic rhinometry results(volume) [1 day]
Changes after surgery compared to before surgery on bilateral nasal cavity volume in acoustic rhinometry result. All measurement will be completed at the time of each patient's initial visit, 1 day
Acoustic rhinometry results(cross sectional area) [1 day]
Changes after surgery compared to before surgery on bilateral nasal cavity cross sectional area in acoustic rhinometry result. All measurement will be completed at the time of each patient's initial visit, 1 day
CT images(cross sectional area) [1 day]
Changes after surgery compared to before surgery on bilateral nasal cavity cross sectional area in CT images. All measurement will be completed at the time of each patient's initial visit, 1 day
CT images(ratio of convex to concave side) [1 day]
Changes after surgery compared to before surgery on nasal cavity ratio of convex to concave side of cross-sectional area in CT images. All measurement will be completed at the time of each patient's initial visit, 1 day
CT images(nasal septum angle) [1 day]
Changes after surgery compared to before surgery on nasal septum angle in CT images. All measurement will be completed at the time of each patient's initial visit, 1 day
Ratio of improvement of regarding symptoms after surgery [1 day]
Symptom improvement is defined as the total NOSE score reduced by more than 40 points compared to before surgery or the total NOSE score less than 20 points after surgery. All measurement will be completed at the time of each patient's initial visit, 1 day The NOSE(Nasal Obstruction Symptom Evaluation) score is a 5-step scale (0(asymptomatic)-4(very severe) points) of the severity of each symptom over the past month for the 5 symptoms related to nasal obstruction (nasal hyperemia / snagging / difficulty in breathing / sleeping disorder / difficulty breathing during exercise). Then, it is evaluated by interviewing the patient. The total score of 20 points is converted to 100 points and recorded.
Level of satisfaction of patients using VAS [1 day]
The patient satisfaction is evaluated using VAS(Visual Analogue Scale). All measurement will be completed at the time of each patient's initial visit, 1 day VAS(Visual Analogue Scles)Scoring and Interpretation Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients who have completed nasal septal deformity surgery using TnR Nasal Mesh.
Females of childbearing potential must have a negative urine pregnancy test, and must not plan to become pregnant during the course of the study.
A person who voluntarily signed a consent form after hearing and understanding the description of this clinical study.

Exclusion Criteria:

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 inflammation in a nasal cavity
Patients with asthma
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 sarcoma or carcinoma in a nasal cavity
Patients with untreated palate-facial disfigurements or cleft palate
Patients with sepsis
Patients with systemic inflammatory disease
Patients who are unsuitable for clinical sturdy determined by the researcher.