Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
A Prospective, Multi-center, Post-Market Clinical Study to Evaluate the Safety and Effectiveness of the REFLEX ULTRA 45 for the Coblation Inferior Turbinate Reduction in China
Smith & Nephew, Inc.
105 participants
Jul 2, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 is willing and able to participate in required follow-up visits and is able to complete study activities.
Exclusion Criteria12
- 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.
- Subject who has nasal obstruction due to inferior turbinate bony hypertrophy.
- Subject who was treated with inferior turbinate reduction before informed consent.
- Subjects who completed the Zung Self-Rating Anxiety Scale and the anxiety rate is more than 59.
- Woman who is pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
- Subject who has participated previously in this clinical trial or who has been withdrawn.
- Subject with a history of poor compliance with medical treatment.
- Subject with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
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Interventions
One time use for surgery
Locations(6)
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NCT07025304