Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05573919
Other study ID # EH22-177
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 7, 2022
Est. completion date October 2024

Study information

Verified date February 2024
Source NorthShore University HealthSystem
Contact Riley J Medenwald, BS
Phone 874-570-3944
Email RMedenwald@northshore.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date October 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
United States Swedish Covenant Hospital Chicago Illinois
United States NorthShore Skokie Hospital Skokie Illinois

Sponsors (1)

Lead Sponsor Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04506346 - Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient
Completed NCT02106143 - RejuvenAirâ„¢ System Lobectomy Safety and Histology Study N/A
Completed NCT03274791 - Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD N/A
Completed NCT01721486 - Acetaminophen's Efficacy For Post-operative Pain Phase 4
Completed NCT01765530 - Efficacy Study of a Novel Device to Clean the Endotracheal Tube N/A
Completed NCT03656315 - Scoring System to Predict Depth of Cricothyroid Membrane N/A
Recruiting NCT05880836 - In Line Aerosol Nebulization With High Flow N/A
Completed NCT02403934 - Jaw Elevation Device in Deep Sedation Study N/A
Recruiting NCT00452062 - Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults Phase 2
Completed NCT02563210 - Airway Resistance Measurement in Children 3 to 6 Years of Age N/A
Completed NCT03488849 - SureCRIC Standardized Patient Study
Completed NCT03752593 - The Incidence of Difficult Intubation in Obese Versus Non-obese Patients
Recruiting NCT05974488 - The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE N/A
Not yet recruiting NCT02975791 - Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane N/A
Completed NCT00788788 - Heliox in Experimental Upper Airway Obstruction Phase 1/Phase 2
Not yet recruiting NCT06128811 - Dental Isolation Systems Among Pediatric Patients With Different Airway Patency N/A
Completed NCT05550220 - A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients N/A
Completed NCT03165461 - Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
Recruiting NCT03969147 - Investigation of a Novel Oropharyngeal Airway: The ManMaxAirway N/A
Completed NCT03604055 - Can Recurrence of Hamartomas be Prevented? N/A