AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - 65 YearsAllSmith & Nephew, Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
๐Ÿ’Š

What it tests

  • REFLEX ULTRA 45
๐Ÿ“

Where

6 sites
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
Jiangsu Province Hospital
Nanjing, China
China-Japan Union Hospital of Jilin University
Changchun, China
Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy