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

• Conditions: Nasal Obstruction; Septal Deformity

• Registration Number: NCT04332575
• Lead Sponsor: T&R Biofab Co., Ltd.

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.

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 Timeline

• Study First Submitted: 2020-03-30
• Status Verified: 2020-04
• Study Start: 2020-04
• Primary Completion: 2020-04
• Study First Submitted QC: 2020-04-01
• Last Update Submitted: 2020-04-01
• Study First Posted: 2020-04-02
• Last Update Posted: 2020-04-03
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

1. Pregnancy or lactation

   • Before screening

2. History of surgery in nasal or paranasal sinuses before screening

3. History of radiation treatment at Head and neck

4. History of having participated in other clinical trial of a drug/ a medical device within three months

   • Screening point

5. Patients with untreated nasal bone fraction or trauma of nasal

6. Patients with surgical site infection caused by nasal bone fraction or trauma

7. Patients with inflammation in a nasal cavity

8. Patients with asthma

9. Patients with untreated a perforation of septum, a sinusitis, a nasal cavity polyposis, a nasal cavity sarcoidosis, nasal valve collapse or wegener's granulomatosis

10. Patients with sarcoma or carcinoma in a nasal cavity

11. Patients with untreated palate-facial disfigurements or cleft palate

12. Patients with sepsis

13. Patients with systemic inflammatory disease

14. Patients who are unsuitable for clinical sturdy determined by the researcher.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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(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.
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
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
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.