Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-06-09; most recent amendment 2026-01-05.
Status change: Not Yet Recruiting → Recruiting 2025-07-09
Trial Details
NCT Number NCT07025304
Lead Sponsor Smith & Nephew, Inc.
Conditions Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Enrollment 105 participants
Start Date 2025-07-02
Primary Completion 2026-09-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-07