Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
NCT ID: NCT07025304
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
105 participants
INTERVENTIONAL
2025-07-02
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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REFLEX ULTRA 45
The investigational product REFLEX ULTRA 45 includes two models which are EIC4845-01 and EICA4845-01. The only difference between these two models is the EICA4845-01 has a maximum two-use limit.
REFLEX ULTRA 45
One time use for surgery
Interventions
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REFLEX ULTRA 45
One time use for surgery
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dongdong Zhu
Role: PRINCIPAL_INVESTIGATOR
China-Japan Union Hospital, Jilin University
Locations
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Guangke Wang
Role: primary
Role: backup
Other Identifiers
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SNIS-E-1198
Identifier Type: -
Identifier Source: org_study_id
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