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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Total NOSE score change after surgery compared to before surgery | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| NOSE score change | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy or lactation
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
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.
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Patients between the ages of 19 and 74, who have completed nasal septal deformity surgery using TnR Nasal Mesh.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeongmin Choi, pm | Contact | 02-2258-7896 | Jeongmin.choi@mediex.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sung-won Kim, professor | The Catholic University of Korea | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25883105 | Background | 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. | |
| 21819753 | Background | 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. |
| Label | URL |
|---|---|
| Description SIDS Initial Assessment Report | View source |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| 1 day |
| Acoustic rhinometry results(volume) | 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 | 1 day |
| Acoustic rhinometry results(cross sectional area) | 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 | 1 day |
| CT images(cross sectional area) | 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 | 1 day |
| CT images(ratio of convex to concave side) | 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 | 1 day |
| CT images(nasal septum angle) | 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 | 1 day |
| Ratio of improvement of regarding symptoms after surgery | 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. | 1 day |
| Level of satisfaction of patients using VAS | 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. | 1 day |
| 22986938 | Background | 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. |
| 20083734 | Background | 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. |
| 21885221 | Background | 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. |
| 15054368 | Background | 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. |
| 23094256 | Background | 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. |
| 21537619 | Background | 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. |
| 26754620 | Background | 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. |
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |