Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction

Nasal Obstruction Clinical Trial

— AERWAY  

Official title:

A Prospective, Multicenter Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04277507
• Other study ID #: TP900
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Aerin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction

Description:

Prospective, Multicenter, Non-randomized Study of the Aerin Medical Vivaer® ARC Stylus for Nasal Airway Obstruction to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 122
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or older

2. Willing and able to provide informed consent

3. Willing and able to comply with the study protocol

4. Seeking treatment for nasal obstruction

5. NOSE score of = 60 at Baseline

6. Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam):

• Use of external nasal dilator strips (e.g., Breathe Right Strips)

• Q-Tip test (manual intranasal lateralization)

• Use of nasal stents

• Cottle Maneuver (manual lateral retraction of the cheek)

Exclusion Criteria:

1. Prior surgical treatment of the nasal valve

2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months

3. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure

4. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.

Related Conditions & MeSH terms

• Airway Obstruction
• Nasal Obstruction

Intervention

Device:
• Vivaer Stylus
Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area

Locations

Country	Name	City	State
United States	Baton Rouge General / Sinus and Nasal Specialists of Louisiana	Baton Rouge	Louisiana
United States	Alabama Nasal and Sinus Center	Birmingham	Alabama
United States	ENT Associates of South Florida	Boca Raton	Florida
United States	Chicago Nasal and Sinus Center	Chicago	Illinois
United States	Arizona Desert ENT Specialists	Goodyear	Arizona
United States	UT Physicians Otorhinolaryngology - Texas Medical Center	Houston	Texas
United States	ENT Associates of Texas	McKinney	Texas
United States	Advocare Aroesty ENT Associates	Mount Arlington	New Jersey
United States	ENT Associates of South Florida	Plantation	Florida
United States	Sacramento ENT	Roseville	California

Sponsors (1)

Lead Sponsor	Collaborator
Aerin Medical

Country where clinical trial is conducted

United States, 

References & Publications (2)

Yao WC, Ow RA, Barham HP (2021) Temperature-Controlled Radiofrequency Treatment of the Nasal Valve and Nasal Airway Obstruction: Early Results of a Prospective, Multi-Center Study. J Otolaryngol Rhinol 7:104. doi.org/10.23937/2572-4193.1510105

Yao WC, Pritikin J, Sillers MJ, Barham HP. Two-year outcomes of temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction. Laryngoscope Investig Otolaryngol. 2023 Jun 15;8(4):808-815. doi: 10.1002 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure	The Pain VAS will be used to rate pain associated with the treatment (Hawker, Mian et al. 2011). Subjects are asked to mark their pain level on a 10 cm line anchored by verbal descriptors: 0 = no pain and 10 = worst pain imaginable. The study staff will measure with a metric ruler from the 0, the beginning of the line, to the vertical mark made by the subject. The result, expressed in millimeters, will represent the subject's VAS Pain Score with 100 being the worst pain imaginable.	3 months post study procedure
Other	Subject Reported Change in Medication Use for Nasal Obstruction Symptoms	Evaluate change (reduction) in medication used for nasal obstruction symptoms from Baseline to follow up timepoints post study procedure of 3 months, 6 months, 12 months and 24 months	24 Month
Other	Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis	Mean change in NOSE score from Baseline to 24 months post study procedure. Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning sever nasal obstructive symptoms	24 Months
Primary	Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months	Mean change in NOSE score from Baseline to 3 months.Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning severe nasal obstructive symptoms.	3 Month