A Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty

Nasal Obstruction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03088618
• Other study ID #: TNRBIOFAB-CTS01
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2017
• Last updated: March 16, 2017
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2017
• Source: T&R Biofab Co., Ltd.
• Contact: Jiwon Park, Manager
• Phone: 02--2014-9566
• Email: park.jiwon[@]lskglobal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Nasal Obstruction
• Septal Deformity

Intervention

Procedure:
• Nasal septoplasty
Type of surgery

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea	Bucheon	Kyunggi-do
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's hospital	Seoul City	Seocho-gu

Sponsors (1)

Lead Sponsor	Collaborator
T&R Biofab Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

Boenisch M, Nolst Trenité 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. — View Citation

Erickson B, Hurowitz R, Jeffery C, Ansari K, El Hakim H, Wright ED, Seikaly H, Greig SR, Côté 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. — View Citation

Garcia LB, Oliveira PW, Vidigal Tde A, Suguri Vde M, Santos Rde P, Gregório LC. Caudal septoplasty: efficacy of a surgical technique-preliminary report. Braz J Otorhinolaryngol. 2011 Mar-Apr;77(2):178-84. English, Portuguese. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Deviant-cases	A follow-up will be performed after the surgery until the end of the clinical trial period. Any newly occurred or worsen symptoms will be recorded.; Preparation content: Deviant-cases name, expression date, disappearance date, severity, gravity, results, a relationship between a medical device, a treatment, a status(remove or not).; All deviant-cases are standardized as System Organ Class (SOC) and Preferred Term (PT) according to Medical Dictionary for regulatory activities (MedDRA). The analysis of deviant-case is based on the Treatment Emergent Adverse Event (TEAE). The percentage and the number of deviant cases and abnormal reactions to the device will be proposed as well as the 95 % of confidence interval of the incidence.	12 weeks
Primary	NOSE total scores at 12 weeks after the surgery	The change in NOSE total scores of the 12th week after the surgery	12 weeks
Secondary	NOSE total scores	The change in NOSE total scores 4 weeks after the surgery	4 weeks
Secondary	NOSE score by topic	NOSE score by topic 4, 12 weeks after the surgery	4 and 12 weeks
Secondary	Acoustic rhinometry results(cross-sectional sum)	Changes in bilateral nasal cavity cross sectional sum in acoustic rhinometry results 4, 12 weeks after the surgery	4 and 12 weeks
Secondary	Acoustic rhinometry results(volume sum)	Changes in bilateral nasal cavity volume sum in acoustic rhinometry results 4, 12 weeks after the surgery	4 and 12 weeks
Secondary	CT images(cross sectional area)	Changes in nasal cavity cross-sectional area in CT images 12 weeks after the surgery	12 weeks
Secondary	CT images(ratio of convex to concave side)	Changes in nasal cavity raio of convex to concave side of cross-sectional area in CT images 12 weeks after the surgery	12 weeks
Secondary	CT images(nasal septum angle)	Changes in nasal septum angle in CT images 12 weeks after the surgery	12 weeks
Secondary	Ratio of improvement regarding symptoms	Ratio of improvement regarding symptoms 12 weeks after surgery	12 weeks
Secondary	Level of satisfaction of patients	Satisfaction score(used visual analogue scale) of subject 12 weeks after surgery	12 weeks

External Links

•   SIDS Initial Assessment Report