Recruiting

VivAer

Sponsor:

Endeavor Health

Code:

NCT05573919

Conditions

Nasal Obstruction

Medically Unexplained Symptoms

Airway Obstruction

Airway Remodeling

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VivAer Stylus

Study Details

Brief summary:

This is a prospective, single-center study. This study seeks to determine the objective improvement in nasal airflow in patients after undergoing the VivAer procedure, which involves the use of a stylus to deliver controlled and targeted low energy radiofrequency heating (heating by applying high-frequency radio waves) to the nasal sidewall to gently reshape the tissues. Patients who experience refractory, or medically unexplained, nasal obstruction often have symptoms that are not alleviated or resolved by standard non-surgical treatment options. VivAer, a recently developed, FDA-approved procedure, is one of the standard surgical treatments for nasal obstruction. Unlike most of the other established surgical treatments for nasal obstruction, however, VivAer is a minimally-invasive procedure, and it is an outpatient intervention that can be performed under local anesthetic. Eligible patients who are enrolled in the study will undergo the VivAer procedure, and will return to the clinic for three in-office follow-up visits at 4, 12, and 24 weeks after the procedure.

Conditions

Nasal Obstruction

Medically Unexplained Symptoms

Airway Obstruction

Airway Remodeling

Study ID

NCT05573919

Start date

Oct 7, 2022

Status verified date

Feb, 2024

Completion date

Oct, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults 18 years and older seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
  • Nasal obstruction, defined as ≥60 by the NOSE scale.
  • The nasal valve is the primary or significant contributor to the subject's nasal obstruction as determined by the investigator, based on clinical presentation, physical examination, or nasal endoscopy.
  • Subjects has symptomatic improvement with use of external or internal nasal dilators, Q-Tip or curette test (manual intranasal lateralization), or the Cottle Maneuver (manual lateral retraction of the cheek).
  • Subject experienced minimal symptomatic improvement after the four-week fluticasone steroid nasal spray regimen.

Exclusion Criteria:

  • Prior surgery to the nasal valve, rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past 12 months.
  • Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy.
  • Severe case of any of the following; septal deviation, turbinate hypertrophy, polyps, or ptotic nasal tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention.
  • Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
  • Known or suspected pregnancy, or lactation.
  • Other medical conditions that the investigator believed would predispose subject to poor wound healing or increased surgical risk.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VivAer Patients

These patients will undergo the VivAer procedure, which involves the use of a stylus to deliver radiofrequency heating to the nasal sidewall to reshape the tissue. This will be done to resolve the patients' nasal obstruction. They will have PNIF measurements taken and will complete symptom assessment questionnaires before and after the VivAer procedure.

Interventions

VivAer Stylus

This device will be used to complete its corresponding procedure, which involves reshaping a patient's nasal sidewall tissue through the delivery of radiofrequency heating.

Primary outcome measure

  • PNIF Measurement [ Time Frame: This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure. ]

Central Contacts and Locations

Central contacts

Riley J Medenwald, BS

874-570-3944RMedenwald@northshore.org

Locations

Swedish Covenant Hospital

Recruiting

Chicago, Illinois, United States, 60625

Contacts

Auddie Sweis, MD

ASweis@northshore.org

Principal Investigator:

Auddie Sweis, MD

NorthShore Skokie Hospital

Recruiting

Skokie, Illinois, United States, 60076

Contacts

Auddie Sweis, MD

ASweis@northshore.org

Principal Investigator:

Auddie Sweis, MD

More Information

Sponsor

Endeavor Health

Last update posted

Feb 21, 2024

Last verified

Feb, 2024

Keywords

  • VivAer
  • Symptom Improvement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2024-02-21.