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 mainland.
Eligibility criteria
Qualifiers
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 inferior turbinate reduction for bilateral nasal cavity without outfracture of inferior turbinate per the investigator's judgement.
Subject is 18 - 65 years old (inclusive).
Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) approved consent form before any study procedures are performed, including pre- operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
Disqualifiers
Subject who does not meet the indication or is contraindicated according to specific REFLEX ULTRA 45 's Instructions for Use (IFUs).
Subject with obvious deviation of nasal septum with the necessity of surgery under investigator's judgement.
Participation in the treatment period of another clinical trial within thirty (30) days of all visits completed.
Subject who needs other nasal surgery other than single inferior turbinate reduction evaluated by MRI and nasal endoscopy.
Trial design
Treatments tested in this trial
- REFLEX ULTRA 45