Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-26 @ 9:23 PM
Study NCT ID:
NCT07025304
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multi-center, Post-Market Clinical Study to Evaluate the Safety and Effectiveness of the REFLEX ULTRA 45 for the Coblation Inferior Turbinate Reduction in China
Status:
RECRUITING
Status Verified Date:
2025-07
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 study is a prospective, multi-center, post-market clinical study to evaluate the safety and effectiveness of REFLEX ULTRA 45 for the coblation inferior turbinate reduction in China. The study product is REFLEX ULTRA 45 (EIC4845-01/EICA4845-01). Also it needs to be performed with the controller system COBLATOR II or WEREWOLF. The sample size is 105 subjects with approximate 6 sites in China mainland.
Detailed Description:
Inferior turbinate hypertrophy (ITH) is a common condition characterized by the enlargement of the inferior turbinate which is mainly due to swelling of the sub-mucosa and rarely due to enlargement of the bone itself. Based on current studies, there are several surgical techniques is being widely used in clinic for ITH includes turbinectomy, electrocautery, laser surgery, cryotherapy, Microdebrider-assisted inferior turbinoplasty (MAIT) and radiofrequency ablation (RFA). The technique used in this study for ITH is Coblation produced by REFLEX ULTRA 45. With limited high quality literature in Chinese population, it is the main purpose to generate high quality evidence among the Chinese population to establish the effectiveness and safety in Chinese population with sufficient outcomes evaluation and appropriate inclusion and exclusion criteria.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: