Status: Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
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.
Participants needed: 105
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Smith & Nephew, Inc.Updated: Jan 7, 2026Locations: 6
Eligibility criteria
Subject with at least two-year history of perennial rhinitis and who has failed... [+4]
Subject who does not meet the indication or is contraindicated according to spec... [+11]