Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438185
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-23
Brief Title:
Efficacy And Safety of An IRE System For Treatment of Inferior Turbinate Hypertrophy
Sponsor:
ENTire Medical Ltd
Organization:
ENTire Medical Ltd
Study Overview
Official Title:
Evaluation of The Efficacy And Safety of An Irreversible Electroporation IRE System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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 the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinates causing nasal obstruction while minimizing side effects and complications Procedure time will also be reduced The IRE System is designed to be more comfortable for patients as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane leading to cell death and the reduction of the inferior turbinate volume
Detailed Description:
The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinates causing nasal obstruction while minimizing side effects and complications Procedure time will also be reduced The IRE System is designed to be more comfortable for patients as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane leading to cell death and the reduction of tonsil volume On basis of these finding and in view of the known safety profile refer to Chen etal and efficacy of current technologies the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in interior turbinate reduction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None