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New nose procedure could rival surgery for blocked breathing

NCT ID NCT06922955

Symptom relief Sponsor: Aerin Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a new, less invasive procedure called VivAer to standard surgery (functional rhinoplasty or septoplasty) for people with nasal airway obstruction. About 400 adults aged 22-85 with severe nasal blockage will be treated. The goal is to see if VivAer works as well as surgery to improve breathing and reduce symptoms.

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.

Participants

About 400 people

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

Started

Feb 2025

Expected to finish

Dec 2027

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.

Who is studied

Patients between the ages of 22-85 seeking treatments for nasal airway obstruction.

Ages

22 to 85 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: * Age 22 to 85 years old (inclusively). * Willing and able to provide consent. * Willing and able to comply with the patient-specific requirements outlined in the study protocol. * Has access to a mobile device, tablet, or computer with internet access and has access to an email address. * Seeking treatment for NAO * Has a NOSE Score of ≥55 indicating severe to extreme NAO. * Have a positive modified Cottle maneuver. * Planning either to undergo an intervention for NAO that includes one of the following as the primary approach: 1. VivAer procedure for repair of nasal valve dysfunction (may include inferior turbinate and septal swell body as additional treated areas) 2. Functional rhinoplasty surgery addressing the nasal valve and/or lateral nasal wall (may be combined with septoplasty with/without turbinoplasty performed alone or in combination). 3. Septoplasty surgery with turbinate reduction. Exclusion Criteria: * Has had nasal surgery (including sinus surgery) within the last 3 months. * Has had a previous rhinoplasty (functional or cosmetic), septoplasty, inferior turbinate reduction, or VivAer procedure. * Has extreme nasal pathology, a history of extreme nasal injuries, or an abnormal nasal condition (e.g. septal perforation or empty nose syndrome) that may be exacerbated by surgery. * Has a medical condition(s) that may impair normal healing processes or be exacerbated by the stress of surgery. * Has chronic rhinitis that is refractory to medications or rhinitis medicamentosa. * Has poorly controlled chronic rhinosinusitis disease. * Rhinoplasty is being performed primarily for cosmesis. * Is receiving, planning to receive, or has received a Latera absorbable nasal implant at any time. * Planning to have sinus or cosmetic surgery (e.g., functional endoscopic sinus surgery, cosmetic rhinoplasty) or a surgery involving the airway (e.g., hypoglossal nerve stimulation surgery, uvuloplasty, tonsillectomy, tongue base or soft palate interventions) within 6 months following enrollment. * Is having an adjunctive surgical procedure performed with the primary NAO procedure (e.g. functional rhinoplasty with concha bullosa reduction, septoplasty with turbinate reduction performed with functional endoscopic sinus surgery)

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Conditions

The condition(s) this trial relates to.

Nasal Obstruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nasal airway obstruction

Contacts and locations

Locations

  • Advanced ENT and Allergy

    Fernandina Beach, Florida, 32034, United States

  • Alamo ENT Associates

    San Antonio, Texas, 78258, United States

  • Alexis Furze, MD Inc

    Newport Beach, California, 92663, United States

  • Arizona Desert ENT Specialists

    Goodyear, Arizona, 85395, United States

  • Bethlehem ENT /Specialty Physician Associates

    Bethlehem, Pennsylvania, 18017, United States

  • Breathe Clear Institute

    Torrance, California, 90503, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Chicago ENT

    Chicago, Illinois, 60657, United States

  • Chicago Nasal and Sinus Center

    Chicago, Illinois, 60602, United States

  • Dearborn ENT

    Dearborn, Michigan, 48124, United States

  • Dearborn ENT Livonia

    Livonia, Michigan, 48154, United States

  • ENT & Allergy Associates

    Puyallup, Washington, 98373, United States

  • ENT & Allergy Associates of Florida (Boynton Beach)

    Boynton Beach, Florida, 33472, United States

  • ENT Associates of Texas

    McKinney, Texas, 75070, United States

  • ENT and Allergy Associates Of Florida

    Port Saint Lucie, Florida, 34952, United States

  • ENT and Allergy Associates of Florida

    Plantation, Florida, 33324, United States

  • ENT and Allergy Associates of Florida (West Palm Beach)

    West Palm Beach, Florida, 33407, United States

  • East Alabama ENT

    Opelika, Alabama, 36801, United States

  • Endormir Sleep Solution LLC

    San Antonio, Texas, 78230, United States

  • ExcelENT

    Birmingham, Alabama, 35244, United States

  • Hill Country ENT

    New Braunfels, Texas, 78130, United States

  • Honor Health ENT

    Scottsdale, Arizona, 85255, United States

  • IMMUNOe Research Center

    Denver, Colorado, 80249, United States

  • Kentuckia Ear Nose & Throat

    Louisville, Kentucky, 40205, United States

  • Maddison ENT

    New York, New York, 10016, United States

  • Madison ENT

    New York, New York, 10016, United States

  • Mercy Medical Group

    Sacramento, California, 95816, United States

  • North Alabama ENT

    Huntsville, Alabama, 35801, United States

  • Open Sinus

    New York, New York, 10019, United States

  • Sacramento ENT (DaVinci Research)

    Roseville, California, 95661, United States

  • Southern Head and Neck Surgery

    Alexander City, Alabama, 35010, United States

  • Texas Facial Plastic Surgery & ENT

    San Antonio, Texas, 78230, United States

  • Tucson ENT

    Tucson, Arizona, 85704, United States

  • University of Rochester

    Rochester, New York, 14627, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

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