Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

NCT04549545 | Completed Results FDA Device

• 1 other identifier: CTP1006
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).

Conditions

Nasal Airway Obstruction

Keywords

Nasal obstruction; NAO; Nasal valve dysfunction; Nasal airway obstruction

Outcome Measures

Primary Outcomes (1)

• Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate

  The Nasal Obstruction Symptom Evaluation (NOSE) Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses.

  3 months visit following the study procedure.

Secondary Outcomes (2)

• Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months

  Change from Baseline to 3 months following the study procedure.

• Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months

  At or following the study procedure up to to 3 months.

Other Outcomes (13)

• NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE Score

  3 Month

• NOSE Scale Score - 3 Month Average

  3 Month

• NOSE Scale Score - 6 Month Average

  6 Month

Study Arms (2)

Vivaer Procedure

ACTIVE COMPARATOR

The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session. Each side of the nose will be treated with up to four (4) non-overlapping applications of RF energy at the junction of the upper and lower lateral cartilage on the lateral nasal wall. Treatment settings to be used are: temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat ("touch up") procedures will be permitted after the initial procedure through the end of the study (24 months).

Device: Vivaer ARC Stylus

Sham Control Procedure

SHAM COMPARATOR

The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Device: Sham

Interventions

Vivaer ARC Stylus DEVICE

The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.

Vivaer Procedure

Sham DEVICE

The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Sham Control Procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85 years (inclusively).
• Willing and able to provide informed consent.
• Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
• Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
• Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥ 55.
• Nasal valve is a primary or significant contributor to the patient's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the patient has a positive response to any of the following temporary measures (based on patient history or office exam):
• Use of external nasal dilator strips (eg, Breathe Right Strips)
• Use of internal nasal dilator cones
• Modified Cottle Maneuver (manual elevation of the lateral nasal wall using a small instrument or cotton-tipped applicator to open the nasal valve)
• Cottle Maneuver (manual lateral retraction of the cheek to open the nasal valve)
• Dissatisfaction with medical management as judged by the patient. Defined as failed medical therapy (eg, decongestants, antihistamines, and/or nasal sprays for an appropriate period of time), but a positive response to internal or external nasal dilators.

You may not qualify if:

• Prior surgery of the lateral nasal wall, including cephalic resection of the lower lateral cartilage, dome division or suture plication, alar graft or spreader graft placement.
• Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (FESS) within the preceding 3 months.
• Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the patient's nasal obstruction symptoms and warranting surgical intervention.
• Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure.
• Known or suspected to be pregnant or is lactating.
• Participating in another clinical research study.
• Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.

Sponsors & Collaborators

• Aerin Medical: lead

Study Sites (12)

Roseville Facial Plastic Surgery

Roseville, California, 95661, United States

Location

Breathe Clear Institute

Torrance, California, 90503, United States

Location

ENT and Allergy Associates of Florida

Coral Springs, Florida, 33065, United States

Location

ENT Associates of South Florida

Fort Lauderdale, Florida, 33301, United States

Location

ENT and Allergy Associates of Florida

Port Saint Lucie, Florida, 34952, United States

Location

Advanced ENT and Allergy KY

Louisville, Kentucky, 40207, United States

Location

Madison ENT

New York, New York, 10016, United States

Location

Piedmont ENT Associates NC

Winston-Salem, North Carolina, 27103, United States

Location

Bethlehem ENT

Bethlehem, Pennsylvania, 18017, United States

Location

ENT Associates of Texas (ENTtex)

McKinney, Texas, 75070, United States

Location

Ogden Clinic

Ogden, Utah, 84403, United States

Location

EVMS Ear Nose and Throat Surgeons

Norfolk, Virginia, 23507, United States

Location

Related Publications (4)

• Silvers SL, Rosenthal JN, McDuffie CM, Yen DM, Han JK. Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial. Int Forum Allergy Rhinol. 2021 Dec;11(12):1676-1684. doi: 10.1002/alr.22861. Epub 2021 Jul 9.

  PMID: 34240571 RESULT

• Han JK, Silvers SL, Rosenthal JN, McDuffie CM, Yen DM. Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction. JAMA Otolaryngol Head Neck Surg. 2022 Oct 1;148(10):940-946. doi: 10.1001/jamaoto.2022.2293.

  PMID: 36048465 RESULT

• Silvers SL, McDuffie CM, Yen DM, Rosenthal JN, Davis SE, Han JK. Two-year outcomes of radiofrequency device treatment of the nasal valve for nasal airway obstruction. Rhinology. 2024 Jun 1;62(3):310-319. doi: 10.4193/RhinRhin23.377.

  PMID: 38217847 RESULT

• Han JK, Rosenthal JN, McDuffie CM, Yen DM, Bikhazi NB, Kakarlapudi VV, Silvers SL. Temperature-Controlled Radiofrequency Treatment of the Nasal Valve in Patients With Nasal Obstruction: Long-Term Outcomes. Otolaryngol Head Neck Surg. 2025 Apr;172(4):1214-1223. doi: 10.1002/ohn.1118. Epub 2025 Jan 17.

  PMID: 39822054 RESULT

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Limitations and Caveats

Medication use was not dictated by the protocol and could affect symptom relief; Data presented are through 12 months and continued follow-up will provide additional data on long term durability. Only subjects with nasal valve collapse as primary NAO were enrolled, but some subjects may have other contributors - for this reason, eligibility exclusion criteria should be considered with results.

Results Point of Contact

• Title: Tien Dang Sr. Clinical Affairs Manager
• Organization: Aerin Medical

tdang@aerinmedical.com

669-256-6596

Study Officials

• Joseph Han, MD

  EVMS Medical Group

  PRINCIPAL INVESTIGATOR

• Stacey Silvers, MD

  Madison ENT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to the study arm they are assigned to.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 site-stratified randomization will be used to allocate participants to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure). Crossover within 30 days after 3 month follow-up visit.

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: August 12, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 4, 2025
• Last Updated: August 28, 2025
• Results First Posted: June 12, 2024

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)