NCT07025304

Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasal Obstruction Due to Inferior Turbinate Hypertrophy

Interventions

Type	Name	Description
DEVICE	REFLEX ULTRA 45	One time use for surgery

Timeline

• Start date: 2025-07-02
• Primary completion: 2026-09-30
• Completion: 2028-06-30
• First posted: 2025-06-17
• Last updated: 2026-01-07

Locations

6 sites across 1 country: China