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

Not Applicable

• Conditions: Septal Deformity; Nasal Obstruction
• Interventions: Procedure: Nasal septoplasty

• Registration Number: NCT03088618
• Lead Sponsor: T&R Biofab Co., Ltd.

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-02-09
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-16
• Last Update Submitted: 2017-03-16
• Study First Posted: 2017-03-23
• Last Update Posted: 2017-03-23
• Primary Completion: 2017-07
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with septal deformity	Nasal septoplasty	To evaluate the safety and efficacy of surgical material for nasal septoplasty in septal deformity patients with nasal obstruction

Primary Outcome Measures

Name	Time	Method
NOSE total scores at 12 weeks after the surgery	12 weeks	The change in NOSE total scores of the 12th week after the surgery

Secondary Outcome Measures

Name	Time	Method
NOSE score by topic	4 and 12 weeks	NOSE score by topic 4, 12 weeks after the surgery
Acoustic rhinometry results(volume sum)	4 and 12 weeks	Changes in bilateral nasal cavity volume sum in acoustic rhinometry results 4, 12 weeks after the surgery
Level of satisfaction of patients	12 weeks	Satisfaction score(used visual analogue scale) of subject 12 weeks after surgery
NOSE total scores	4 weeks	The change in NOSE total scores 4 weeks after the surgery
CT images(cross sectional area)	12 weeks	Changes in nasal cavity cross-sectional area in CT images 12 weeks after the surgery
Acoustic rhinometry results(cross-sectional sum)	4 and 12 weeks	Changes in bilateral nasal cavity cross sectional sum in acoustic rhinometry results 4, 12 weeks after the surgery
CT images(ratio of convex to concave side)	12 weeks	Changes in nasal cavity raio of convex to concave side of cross-sectional area in CT images 12 weeks after the surgery
CT images(nasal septum angle)	12 weeks	Changes in nasal septum angle in CT images 12 weeks after the surgery
Ratio of improvement regarding symptoms	12 weeks	Ratio of improvement regarding symptoms 12 weeks after surgery

Trial Locations

Locations (2)

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, Korea, Republic of