New nasal device aims to unblock stuffy noses
NCT ID NCT07025304
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a device called REFLEX ULTRA 45 to safely and effectively reduce nasal obstruction caused by enlarged turbinates (tissue inside the nose). About 105 adults who have not gotten relief from nasal sprays will receive the procedure. The main goal is to see if their nasal breathing improves 3 months after treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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China-Japan Union Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130033, China
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Henan Provincial People's Hospital
RECRUITINGZhengzhou, Henan, 462000, China
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Jiangsu Province Hospital
RECRUITINGNanjing, Jiangsu, 210003, China
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Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310016, China
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The First Affiliated Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510080, China
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The Third Affiliated Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510630, China