REFLEX ULTRA 45 coblation treatment for enlarged inferior turbinates
Official title: 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
Run by Smith & Nephew, Inc. · NCT07025304 · Data updated 2026-11-12
This study will try the REFLEX ULTRA 45 coblation device to reduce enlarged inferior turbinates and improve nasal blockage in adults 18–65 who have not improved after one month of nasal steroid spray.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | Smith & Nephew, Inc. Industry-sponsored |
| Locations | 6 sites (Guangzhou, Guangdong and 5 other locations) |
| Status | Recruiting |
| Started | July 2, 2025 |
| Main results expected | March 30, 2027 |
| Study ends | June 30, 2030 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07025304 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with at least a two-year history of perennial rhinitis, nasal obstruction from inferior turbinate hypertrophy, failure of one month of continuous nasal steroid spray, and judged suitable for bilateral coblation turbinate reduction are ideal candidates.
✕Probably not a fit
Patients outside the 18–65 age range, those contraindicated by the device labeling, those whose obstruction is due to significant bony turbinate enlargement or other surgical needs (e.g., requiring outfracture), or those unwilling/unable to attend follow-up may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multi-center, post-market study in mainland China testing coblation inferior turbinate reduction using the REFLEX ULTRA 45 device with the COBLATOR II or WEREWOLF controller. About 105 adults across approximately six sites will undergo bilateral coblation turbinate reduction and attend scheduled follow-up visits for safety and effectiveness measurements. Outcomes will include symptom relief, device- and procedure-related adverse events, and other clinical measures over the follow-up period. The goal is to generate high-quality evidence on performance and safety specifically in a Chinese patient population.
Why it matters
Potential benefit: If successful, the procedure could meaningfully reduce nasal obstruction and improve breathing with a minimally invasive outpatient technique.
How similar studies have gone: Coblation and other radiofrequency techniques for turbinate reduction have shown positive results internationally, but high-quality data in Chinese populations are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject with at least two-year history of perennial rhinitis and who has failed standardized treatment with hormonal nasal spray before the planned 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, as confirmed by either MRI or endoscopy, than single inferior turbinate reduction * 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. * Subject who has participated previously in this clinical trial or who has been withdrawn. * Subject with a history of poor compliance with medical treatment per investigator's opinion. * Subject with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Where it's running
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting -
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting -
Henan Provincial People's Hospital
Zhengzhou, Henan, China Recruiting -
Jiangsu Province Hospital
Nanjing, Jiangsu, China Recruiting -
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China Recruiting -
Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Dongdong Zhu — China-Japan Union Hospital, Jilin University
- Study coordinator: Cathy Xiao
- Email: Cathy.xiao@smith-nephew.com
- Phone: +86 18221637315
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.