Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China

Launched by SMITH & NEPHEW, INC. · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medical device called REFLEX ULTRA 45, which is used to help people who have trouble breathing through their nose because of swelling in a part of the nose called the inferior turbinate. This swelling can make it hard to breathe and is often caused by long-term nasal allergies or inflammation. The study aims to see if using REFLEX ULTRA 45 with a special treatment system (called COBLATOR II or WEREWOLF) is safe and effective for reducing this swelling in patients in China.

People who might be eligible for this study are adults aged 18 to 65 who have had nasal allergy symptoms for at least two years and have not improved after using nasal steroid sprays for at least one month. Participants should have nasal blockage due to swelling of the inferior turbinate but should not need other types of nasal surgery. Before joining, they will give written consent and agree to follow-up visits to monitor their progress. The study will take place at about six centers in China and plans to enroll around 105 participants. Those interested should be prepared for treatment using the REFLEX ULTRA 45 device and regular check-ups to see how well the treatment works and ensure it is safe.

Gender

ALL

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 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 Criteria:
• • 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.