Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New nasal device aims to unblock stuffy noses

NCT ID NCT07025304

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Nasal obstruction due to inferior turbinate hypertrophy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • China-Japan Union Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130033, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 462000, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210003, China

  • Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • The Third Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510630, China