A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.

Last updated: March 20, 2026
Sponsor: Aerin Medical
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Acute Rhinitis

Bronchiectasis

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT06922955
CTP1563
  • Ages 22-85
  • All Genders

Study Summary

The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.

Eligibility Criteria

Inclusion

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 thestudy protocol.

  • Has access to a mobile device, tablet, or computer with internet access and hasaccess 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 thefollowing as the primary approach:

  1. VivAer procedure for repair of nasal valve dysfunction (may include inferiorturbinate and septal swell body as additional treated areas)

  2. Functional rhinoplasty surgery addressing the nasal valve and/or lateral nasalwall (may be combined with septoplasty with/without turbinoplasty performedalone or in combination).

  3. Septoplasty surgery with turbinate reduction.

Exclusion

Exclusion Criteria:

  • Has had nasal surgery (including sinus surgery) within the last 3 months.

  • Has had a previous rhinoplasty (functional or cosmetic), septoplasty, inferiorturbinate reduction, or VivAer procedure.

  • Has extreme nasal pathology, a history of extreme nasal injuries, or an abnormalnasal condition (e.g. septal perforation or empty nose syndrome) that may beexacerbated by surgery.

  • Has a medical condition(s) that may impair normal healing processes or beexacerbated 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 implantat any time.

  • Planning to have sinus or cosmetic surgery (e.g., functional endoscopic sinussurgery, cosmetic rhinoplasty) or a surgery involving the airway (e.g., hypoglossalnerve stimulation surgery, uvuloplasty, tonsillectomy, tongue base or soft palateinterventions) 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 withturbinate reduction performed with functional endoscopic sinus surgery)

Study Design

Total Participants: 400
Study Start date:
February 28, 2025
Estimated Completion Date:
December 31, 2027

Study Description

The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority by using the NOSE scale to evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint.

Connect with a study center

  • Southern Head and Neck Surgery

    Alexander City, Alabama 35010
    United States

    Site Not Available

  • ExcelENT

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • North Alabama ENT

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • East Alabama ENT

    Opelika, Alabama 36801
    United States

    Site Not Available

  • Southern Head and Neck Surgery

    Alexander City 4829843, Alabama 4829764 35010
    United States

    Site Not Available

  • ExcelENT

    Birmingham 4049979, Alabama 4829764 35244
    United States

    Site Not Available

  • North Alabama ENT

    Huntsville 4068590, Alabama 4829764 35801
    United States

    Site Not Available

  • East Alabama ENT

    Opelika 4081644, Alabama 4829764 36801
    United States

    Site Not Available

  • Arizona Desert ENT Specialists

    Goodyear, Arizona 85395
    United States

    Site Not Available

  • Honor Health ENT

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Tucson ENT

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Arizona Desert ENT Specialists

    Goodyear 5296266, Arizona 5551752 85395
    United States

    Site Not Available

  • Honor Health ENT

    Scottsdale 5313457, Arizona 5551752 85255
    United States

    Site Not Available

  • Tucson ENT

    Tucson 5318313, Arizona 5551752 85704
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Alexis Furze, MD Inc

    Newport Beach, California 92663
    United States

    Site Not Available

  • Sacramento ENT (DaVinci Research)

    Roseville, California 95661
    United States

    Site Not Available

  • Mercy Medical Group

    Sacramento, California 95816
    United States

    Site Not Available

  • Breathe Clear Institute

    Torrance, California 90503
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Alexis Furze, MD Inc

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • Sacramento ENT (DaVinci Research)

    Roseville 5388881, California 5332921 95661
    United States

    Site Not Available

  • Mercy Medical Group

    Sacramento 5389489, California 5332921 95816
    United States

    Site Not Available

  • Breathe Clear Institute

    Torrance 5403022, California 5332921 90503
    United States

    Site Not Available

  • IMMUNOe Research Center

    Denver, Colorado 80249
    United States

    Site Not Available

  • IMMUNOe Research Center

    Denver 5419384, Colorado 5417618 80249
    United States

    Site Not Available

  • ENT & Allergy Associates of Florida (Boynton Beach)

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Advanced ENT and Allergy

    Fernandina Beach, Florida 32034
    United States

    Site Not Available

  • ENT and Allergy Associates of Florida

    Plantation, Florida 33324
    United States

    Site Not Available

  • ENT and Allergy Associates Of Florida

    Port Saint Lucie, Florida 34952
    United States

    Site Not Available

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

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • ENT & Allergy Associates of Florida (Boynton Beach)

    Boynton Beach 4148677, Florida 4155751 33472
    United States

    Site Not Available

  • Advanced ENT and Allergy

    Fernandina Beach 4155006, Florida 4155751 32034
    United States

    Site Not Available

  • ENT and Allergy Associates of Florida

    Plantation 4168782, Florida 4155751 33324
    United States

    Site Not Available

  • ENT and Allergy Associates Of Florida

    Port Saint Lucie 4169171, Florida 4155751 34952
    United States

    Site Not Available

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

    West Palm Beach 4177887, Florida 4155751 33407
    United States

    Site Not Available

  • Chicago ENT

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Chicago Nasal and Sinus Center

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Chicago ENT

    Chicago 4887398, Illinois 4896861 60657
    United States

    Site Not Available

  • Chicago Nasal and Sinus Center

    Chicago 4887398, Illinois 4896861 60602
    United States

    Active - Recruiting

  • Kentuckia Ear Nose & Throat

    Louisville, Kentucky 40205
    United States

    Site Not Available

  • Kentuckia Ear Nose & Throat

    Louisville 4299276, Kentucky 6254925 40205
    United States

    Site Not Available

  • Dearborn ENT

    Dearborn, Michigan 48124
    United States

    Site Not Available

  • Dearborn ENT Livonia

    Livonia, Michigan 48154
    United States

    Site Not Available

  • Dearborn ENT

    Dearborn 4990510, Michigan 5001836 48124
    United States

    Site Not Available

  • Dearborn ENT Livonia

    Livonia 4999837, Michigan 5001836 48154
    United States

    Site Not Available

  • Maddison ENT

    New York, New York 10016
    United States

    Site Not Available

  • Madison ENT

    New York, New York 10016
    United States

    Site Not Available

  • Open Sinus

    New York, New York 10019
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14627
    United States

    Site Not Available

  • Maddison ENT

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Madison ENT

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Open Sinus

    New York 5128581, New York 5128638 10019
    United States

    Site Not Available

  • University of Rochester

    Rochester 5134086, New York 5128638 14627
    United States

    Site Not Available

  • Bethlehem ENT /Specialty Physician Associates

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Bethlehem ENT /Specialty Physician Associates

    Bethlehem 5180225, Pennsylvania 6254927 18017
    United States

    Site Not Available

  • ENT Associates of Texas

    McKinney, Texas 75070
    United States

    Site Not Available

  • Hill Country ENT

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • Alamo ENT Associates

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Endormir Sleep Solution LLC

    San Antonio, Texas 78230
    United States

    Site Not Available

  • Texas Facial Plastic Surgery & ENT

    San Antonio, Texas 78230
    United States

    Site Not Available

  • ENT Associates of Texas

    McKinney 4710178, Texas 4736286 75070
    United States

    Site Not Available

  • Hill Country ENT

    New Braunfels 4714131, Texas 4736286 78130
    United States

    Site Not Available

  • Alamo ENT Associates

    San Antonio 4726206, Texas 4736286 78258
    United States

    Active - Recruiting

  • Endormir Sleep Solution LLC

    San Antonio 4726206, Texas 4736286 78230
    United States

    Site Not Available

  • Texas Facial Plastic Surgery & ENT

    San Antonio 4726206, Texas 4736286 78230
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • University of Virginia

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Site Not Available

  • ENT & Allergy Associates

    Puyallup, Washington 98373
    United States

    Site Not Available

  • ENT & Allergy Associates

    Puyallup 5807575, Washington 5815135 98373
    United States

    Site Not Available

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