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.
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).
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.
Single group
REFLEX ULTRA 45
DeviceOne time use for surgery
Nasal Obstruction Symptom Evaluation (NOSE) score at 3 Months
Nasal Obstruction Symptom Evaluation (NOSE) consists of 5 questions regarding nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through nose, trouble sleeping, and ability to get enough air through nose during exercise or exertion. NOSE scores range from 0 to 100, with a higher score indicating a severe problem (i.e., worse outcome) and lower score indicating no problem (i.e., better outcome).
Nasal Obstruction Symptom Evaluation (NOSE) score
Nasal Obstruction Symptom Evaluation (NOSE) consists of 5 questions regarding nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through nose, trouble sleeping, and ability to get enough air through nose during exercise or exertion. NOSE scores range from 0 to 100, with a higher score indicating a severe problem (i.e., worse outcome) and lower score indicating no problem (i.e., better outcome).
36-Item Short Form Survey (SF-36)
The 36-Item short form survey instrument taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Possible scores range from 0 to 100 for each item, with higher scores indicating a better outcome.
Unilateral Nasal Resistance
Nasal resistance is an objective indicator of nasal respiratory function, measured using a rhinomanometry device. During the assessment, the participant breathes air into a tube connected to the rhinomanometry device. The device measures the air pressure and rate of airflow, which are then used to calculate nasal resistance. Increased nasal resistance values indicate nasal obstruction. Unilateral nasal resistance measures the resistance to airflow through one nostril at a time.
Total Nasal Resistance
Nasal resistance is an objective indicator of nasal respiratory function, measured using a rhinomanometry device. During the assessment, the participant breathes air into a tube connected to the rhinomanometry device. The device measures the air pressure and rate of airflow, which are then used to calculate nasal resistance. Increased nasal resistance values indicate nasal obstruction. Total nasal resistance measures the combined resistance to airflow through both nostrils simultaneously.
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