Clinical trial NCT04332575: Clinical Extend Study to Evaluate Safety and Effectiveness of TnR Nasal Mesh for Correction of Nasal Septum on Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septal Deformity
Nasal Obstruction
Keywords: Nasal obstruction
Septal deformity
Septoplasty
TnR Nasal Mesh
polycaprolactone
Lead sponsor: T&R Biofab Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 19 and 74, who have completed nasal septal deformity surgery using TnR Nasal Mesh.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total NOSE score change after surgery compared to before surgery
timeFrame: 1 day
Secondary outcomes:
measure: NOSE score change
timeFrame: 1 day
measure: Acoustic rhinometry results(volume)
timeFrame: 1 day
measure: Acoustic rhinometry results(cross sectional area)
timeFrame: 1 day
measure: CT images(cross sectional area)
timeFrame: 1 day
measure: CT images(ratio of convex to concave side)
timeFrame: 1 day
measure: CT images(nasal septum angle)
timeFrame: 1 day
measure: Ratio of improvement of regarding symptoms after surgery
timeFrame: 1 day
measure: Level of satisfaction of patients using VAS
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: The Catholic University of Korea
name: Sung-won Kim, professor
role: STUDY_DIRECTOR
References:
citation: Surowitz J, Lee MK, Most SP. Anterior Septal Reconstruction for Treatment of Severe Caudal Septal Deviation: Clinical Severity and Outcomes. Otolaryngol Head Neck Surg. 2015 Jul;153(1):27-33. doi: 10.1177/0194599815582176. Epub 2015 Apr 16.
citation: Kim JH, Kim DY, Jang YJ. Outcomes after endonasal septoplasty using caudal septal batten grafting. Am J Rhinol Allergy. 2011 Jul-Aug;25(4):e166-70. doi: 10.2500/ajra.2011.25.3648.
citation: Rimmer J, Ferguson LM, Saleh HA. Versatile applications of the polydioxanone plate in rhinoplasty and septal surgery. Arch Facial Plast Surg. 2012 Sep-Oct;14(5):323-30. doi: 10.1001/archfacial.2012.147.
citation: Boenisch M, Nolst Trenite GJ. Reconstruction of the nasal septum using polydioxanone plate. Arch Facial Plast Surg. 2010 Jan-Feb;12(1):4-10. doi: 10.1001/archfacial.2009.103.
citation: Kahveci OK, Miman MC, Yucel A, Yucedag F, Okur E, Altuntas A. The efficiency of Nose Obstruction Symptom Evaluation (NOSE) scale on patients with nasal septal deviation. Auris Nasus Larynx. 2012 Jun;39(3):275-9. doi: 10.1016/j.anl.2011.08.006. Epub 2011 Aug 31.
citation: Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004.
citation: Kim JN, Choi HG, Kim SH, Park HJ, Shin DH, Jo DI, Kim CK, Uhm KI. The efficacy of bioabsorbable mesh as an internal splint in primary septoplasty. Arch Plast Surg. 2012 Sep;39(5):561-4. doi: 10.5999/aps.2012.39.5.561. Epub 2012 Sep 12.
citation: Garcia LB, Oliveira PW, Vidigal Tde A, Suguri Vde M, Santos Rde P, Gregorio LC. Caudal septoplasty: efficacy of a surgical technique-preliminary report. Braz J Otorhinolaryngol. 2011 Mar-Apr;77(2):178-84. doi: 10.1590/s1808-86942011000200007.
citation: Erickson B, Hurowitz R, Jeffery C, Ansari K, El Hakim H, Wright ED, Seikaly H, Greig SR, Cote DW. Acoustic rhinometry and video endoscopic scoring to evaluate postoperative outcomes in endonasal spreader graft surgery with septoplasty and turbinoplasty for nasal valve collapse. J Otolaryngol Head Neck Surg. 2016 Jan 12;45:2. doi: 10.1186/s40463-016-0115-9.