Clinical trial NCT03088618: A Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty
Official title: A Multi-center, Non-randomized, Open, Single-arm Confirmatory Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty in Septal Deformity Patients With Nasal Obstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septal Deformity
Nasal Obstruction
Keywords: Nasal obstruction
Septal deformity
Septoplasty
TnR Mesh
polycaprolactone
Lead sponsor: T&R Biofab Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-23
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate safety and efficacy of TnR mesh for patients who need nasal septoplasty for septal deformity with 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 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 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 the efficacy and safety of TnR mesh as a material for nasal septoplasty.

Eligibility criteria: Inclusion Criteria:

1. Patients with nasal septal deformity who require surgical treatment
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.

Exclusion Criteria:

1. Known allergic reaction to medical devices(TnR mesh) of the clinical trial
2. Pregnancy or lactation

   - Before screening
3. History of surgery in nasal or paranasal sinuses before screening
4. History of radiation treatment at Head and neck
5. History of having participated in other clinical trial of a drug/ a medical device within three months

   - Screening point
6. Patients with untreated nasal bone fraction or trauma of nasal
7. Patients with surgical site infection caused by nasal bone fraction or trauma
8. Patients with untreated a perforation of septum, a sinusitis, a nasal cavity polyposis, a nasal cavity sarcoidosis, nasal valve collapse or wegener's granulomatosis
9. Patients with inflammation in a nasal cavity
10. Patients with sarcoma or carcinoma in a nasal cavity
11. Patients with asthma
12. Patients with untreated palate-facial disfigurements or cleft palate
13. Patients with systemic inflammatory disease
14. Patients with sepsis

Primary outcomes:
measure: NOSE total scores at 12 weeks after the surgery
timeFrame: 12 weeks
Secondary outcomes:
measure: NOSE total scores
timeFrame: 4 weeks
measure: NOSE score by topic
timeFrame: 4 and 12 weeks
measure: Acoustic rhinometry results(cross-sectional sum)
timeFrame: 4 and 12 weeks
measure: Acoustic rhinometry results(volume sum)
timeFrame: 4 and 12 weeks
measure: CT images(cross sectional area)
timeFrame: 12 weeks
measure: CT images(ratio of convex to concave side)
timeFrame: 12 weeks
measure: CT images(nasal septum angle)
timeFrame: 12 weeks
measure: Ratio of improvement regarding symptoms
timeFrame: 12 weeks
measure: Level of satisfaction of patients
timeFrame: 12 weeks
Other outcomes:
measure: Deviant-cases
timeFrame: 12 weeks
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea
state: Kyunggi-do
city: Seoul City
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's hospital
state: Seocho-gu
Study officials:
affiliation: The Catholic University of Korea
name: Sung-won Kim, professor
role: STUDY_DIRECTOR
affiliation: The Catholic University of Korea Bucheon St.Mary's Hospital
name: Se-Hwan Hwang, 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.