Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Recruiting
N/A
Interventional Study
Nasal Obstruction Due to Inferior Turbinate Hypertrophy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 105 (estimated)
- Sponsor
- Smith & Nephew, Inc. · Industry
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About This Trial
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 mai…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subject with at least two-year history of perennial rhinitis and who has failed one month of continuous standardized treatment with hormonal nasal spray by the date of surgery.
* Subject with nasal obstruction due to turbinate hypertrophy and is suitable to receive coblation i…
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