Ignite Creation Date:
2024-05-06 @ 9:50 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03088618
Status:
UNKNOWN
Last Update Posted:
2017-03-23
First Post:
2017-02-09
Brief Title:
A Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty
Sponsor:
TR Biofab Co Ltd
Organization:
TR Biofab Co Ltd
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None