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

T&R Biofab

Status: Unknown

Conditions: Nasal Obstruction; Septal Deformity

Study type: Observational

Funder types: Industry

Identifiers

NCT04332575

TRBF-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.