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

Last updated: April 9, 2025
Sponsor: Aerin Medical
Overall Status: Active - 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.

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

  • Functional rhinoplasty surgery addressing the nasal valve and/or lateral nasal wall (may be combined with septoplasty and/or turbinoplasty performed alone or incombination).

  • Septoplasty alone or in combination 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 to address NAO symptoms.

  • 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.

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

  • Chicago Nasal and Sinus Center

    Chicago, Illinois 60602
    United States

    Active - Recruiting

  • Kentuckia Ear Nose & Throat

    Louisville, Kentucky 40205
    United States

    Active - Recruiting

  • Maddison ENT

    New York, New York 10016
    United States

    Active - Recruiting

  • Bethlehem ENT /Specialty Physician Associates

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • Hill Country ENT

    New Braunfels, Texas 78130
    United States

    Active - Recruiting

  • Alamo ENT Associates

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • Texas Facial Plastic Surgery & ENT

    San Antonio, Texas 78230
    United States

    Active - Recruiting

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