Actively Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Led by Smith & Nephew, Inc. · Updated on 2026-01-07
105
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have had perennial rhinitis symptoms for at least two years and did not improve after one month of continuous hormonal nasal spray treatment
- Have nasal obstruction caused by turbinate swelling and are suitable for coblation inferior turbinate reduction without outfracture on both sides
- Are between 18 and 65 years old
- Provide written informed consent before any study procedures
- Are willing and able to attend follow-up visits and complete study activities
You will not qualify if you...
- Do not meet the REFLEX ULTRA 45 device instructions for use or have contraindications
- Have significant nasal septum deviation requiring surgery
- Are participating in another clinical trial treatment within 30 days of study visits
- Need nasal surgery other than single inferior turbinate reduction
- Have nasal obstruction caused by bony enlargement of the inferior turbinate
- Have had prior inferior turbinate reduction treatment before consent
- Have anxiety scores over 59 on the Zung Self-Rating Anxiety Scale
- Are pregnant, nursing, or of child-bearing potential without effective birth control
- Are classified as vulnerable subjects per ISO 14155 Section 3.55
- Previously participated or were withdrawn from this trial
- Have a history of poor compliance with medical treatment
- Have medical or physical conditions that would prevent safe participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 6 locations
1
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
2
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
3
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 462000
Actively Recruiting
4
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210003
Actively Recruiting
5
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 130033
Actively Recruiting
6
Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
Research Team
C
Cathy Xiao
CONTACT
J
Julian Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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