VivAer: A Correlation Between Symptom Scores and Objective Findings

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.

Study Overview

• Status: Recruiting
• Conditions: Medically Unexplained Symptoms; Airway Obstruction; Nasal Obstruction; Airway Remodeling
• Intervention / Treatment: Device: VivAer Stylus

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riley J Medenwald, BS; Phone Number: 874-570-3944; Email: RMedenwald@northshore.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60625
      • Recruiting
      • Swedish Covenant Hospital
      • Contact: Auddie Sweis, MD; Email: ASweis@northshore.org
      • Principal Investigator: Auddie Sweis, MD
    • Skokie, Illinois, United States, 60076
      • Recruiting
      • NorthShore Skokie Hospital
      • Contact: Auddie Sweis, MD; Email: ASweis@northshore.org
      • Principal Investigator: Auddie Sweis, MD
      • Principal Investigator: Joseph Raviv, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PNIF Measurement	The change in the severity of the patients' nasal obstruction will be measured using a Peak Nasal Inspiratory Flow (PNIF) meter. This meter measures nasal patency by measuring the volume of air that is inhaled per minute during normal breathing.	This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NOSE Score	The patients will self-assess the degree of their symptoms with the Nasal Obstructive Symptom Evaluation (NOSE) questionnaire. The questionnaire consists of 5 questions ranking the severity of one's symptoms on a scale of 0-5. The responses are summed and multiplied by 20 to generate a symptom score out of 0-100. Higher scores indicate worse outcomes.	This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.
SNOT-22 Score	The patients will self-assess the degree of their symptoms with the SinoNasal Outcome Test (SNOT-22) questionnaire. The questionnaire consists of 22 questions ranking the impact of a patient's symptoms on their quality of life on a scale of 0-5. The responses are summed to generate a score out of 110. Higher scores indicate worse outcomes.	This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Investigators: Principal Investigator: Auddie Sweis, MD, NorthShore University Healthsystem; Principal Investigator: Joseph Raviv, MD, NorthShore University Healthsystem

Publications and helpful links

General Publications

• Jacobowitz O, Driver M, Ephrat M. In-office treatment of nasal valve obstruction using a novel, bipolar radiofrequency device. Laryngoscope Investig Otolaryngol. 2019 Feb 4;4(2):211-217. doi: 10.1002/lio2.247. eCollection 2019 Apr.
• Ephrat M, Jacobowitz O, Driver M. Quality-of-life impact after in-office treatment of nasal valve obstruction with a radiofrequency device: 2-year results from a multicenter, prospective clinical trial. Int Forum Allergy Rhinol. 2021 Apr;11(4):755-765. doi: 10.1002/alr.22667. Epub 2020 Aug 9.
• Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004.
• Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. 2013 Sep-Oct;15(5):358-61. doi: 10.1001/jamafacial.2013.344.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: VivAer; Symptom Improvement
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction; Airway Remodeling; Medically Unexplained Symptoms
• Other Study ID Numbers: EH22-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes