Clinical trial NCT05573919: VivAer: A Correlation Between Symptom Scores and Objective Findings
Official title: VivAer: A Correlation Between Symptom Scores and Objective Findings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasal Obstruction
Medically Unexplained Symptoms
Airway Obstruction
Airway Remodeling
Keywords: VivAer
Symptom Improvement
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: PNIF Measurement
timeFrame: This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.
Secondary outcomes:
measure: NOSE Score
timeFrame: This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.
measure: SNOT-22 Score
timeFrame: This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Swedish Covenant Hospital
state: Illinois
city: Skokie
country: United States
facility: NorthShore Skokie Hospital
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Auddie Sweis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endeavor Health
name: Joseph Raviv, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.