VivAer: A Correlation Between Symptom Scores and Objective Findings

NCT05573919 | Recruiting FDA Device

• 1 other identifier: EH22-177
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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

Keywords

VivAer; Symptom Improvement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• NOSE Score

  This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.

• SNOT-22 Score

  This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.

Study Arms (1)

VivAer Patients

EXPERIMENTAL

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

Interventions

VivAer Stylus DEVICE

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.

VivAer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (2)

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

RECRUITING

NorthShore Skokie Hospital

Skokie, Illinois, 60076, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 31024989 BACKGROUND

• 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.

  PMID: 32810380 BACKGROUND

• 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.

  PMID: 15054368 BACKGROUND

• 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.

  PMID: 23846399 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction; Medically Unexplained Symptoms; Airway Obstruction; Airway Remodeling

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Auddie Sweis, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

• Joseph Raviv, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riley J Medenwald, BS

CONTACT

874-570-3944; RMedenwald@northshore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients who are to undergo the VivAer procedure for nasal obstruction with Dr. Auddie Sweis or Dr. Joseph Raviv will be recruited to this study. They will be issued questionnaires and have PNIF measurements taken to assess their symptoms before and after the procedure in order to determine the objective improvement in the patients' symptoms.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 10, 2022
• Study Start: October 7, 2022
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)