Trial Outcomes & Findings for Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (NCT NCT04277507)

Last Updated: 2025-05-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

122 participants

Primary outcome timeframe

3 Month

Results posted on

2025-05-04

Participant Flow

Study enrollment was "Up to 125 treated patients" to be enrolled in the study at up to 20 sites (medical clinics) in the United States. Recruitment occurred 01FEB2020 - 26AUG2020.

Participant milestones

Participant milestones
Measure	Vivaer Treatment Single Arm Study. Eligible subjects who have signed consent and qualify will have their nasal valve treated in a single Vivaer® treatment session and will be considered enrolled once the device has entered the nasal cavity.
Overall Study STARTED	122
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Vivaer Treatment Single Arm Study. Eligible subjects who have signed consent and qualify will have their nasal valve treated in a single Vivaer® treatment session and will be considered enrolled once the device has entered the nasal cavity.
Overall Study Lost to Follow-up	17
Overall Study Completed through 24M but not interested in extension to 36M	3
Overall Study Received Treatment Outside of Study that could affect study results	2
Overall Study Withdrawal by Subject	3
Overall Study Death due to COVID-19	1
Overall Study Data missing for full evaluation	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vivaer Treatment n=122 Participants Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Age, Customized <60 years	83 Participants n=5 Participants
Age, Customized >=60 years	39 Participants n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Race/Ethnicity, Customized White	107 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian, White	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American, White	1 Participants n=5 Participants
Race/Ethnicity, Customized Declined Available Choices	5 Participants n=5 Participants
Baseline NOSE Scale Score	80.3 units on a scale STANDARD_DEVIATION 12.6 • n=5 Participants
Body Mass Index	27.6 Kg/m^2 STANDARD_DEVIATION 6.7 • n=5 Participants
Nasal Valve Collapse Mechanism Bilateral Dynamic	68 Participants n=5 Participants
Nasal Valve Collapse Mechanism Bilateral Static	47 Participants n=5 Participants
Nasal Valve Collapse Mechanism Unilateral Dynamic	2 Participants n=5 Participants
Nasal Valve Collapse Mechanism Unilateral Dynamic and Unilateral Static	2 Participants n=5 Participants
Nasal Valve Collapse Mechanism Unilateral Static	1 Participants n=5 Participants
Nasal Valve Collapse Mechanism Unreported	2 Participants n=5 Participants
Additional Nasal Obstruction Diagnosis Nasal Valve Stenosis	64 Participants n=5 Participants
Additional Nasal Obstruction Diagnosis Septal Turbinate (Nasal Septal Body)	37 Participants n=5 Participants
Additional Nasal Obstruction Diagnosis Septal Deviation	34 Participants n=5 Participants
Additional Nasal Obstruction Diagnosis Turbinate Enlargement	31 Participants n=5 Participants
Additional Nasal Obstruction Diagnosis Nasal Polyps	3 Participants n=5 Participants
History of Nasal Surgery	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Month

Outcome measures

Outcome measures
Measure	Protocol Eligible Subjects n=119 Participants Scores per-protocol eligible subjects total 119 at 3M	Subjects Using Nasal Sprays for NAO Symptoms Subject using nasal sprays at baseline for the relief of NAO symptoms
Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months	-47.6 score on a scale Standard Error 26.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months post study procedure

Population: All treated subjects VAS score at 3 months post 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.

Outcome measures

Outcome measures
Measure	Protocol Eligible Subjects n=122 Participants Scores per-protocol eligible subjects total 119 at 3M	Subjects Using Nasal Sprays for NAO Symptoms Subject using nasal sprays at baseline for the relief of NAO symptoms
Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure	4.5 millimeters Standard Deviation 8.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Month

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

Outcome measures

Outcome measures
Measure	Protocol Eligible Subjects n=63 Participants Scores per-protocol eligible subjects total 119 at 3M	Subjects Using Nasal Sprays for NAO Symptoms n=66 Participants Subject using nasal sprays at baseline for the relief of NAO symptoms
Subject Reported Change in Medication Use for Nasal Obstruction Symptoms	31 Participants	34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Months

Population: A total of 1010 patients reached 2 year follow-up, of which, 12 had an additional nasal procedure and were reviewed separately

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

Outcome measures

Outcome measures
Measure	Protocol Eligible Subjects n=89 Participants Scores per-protocol eligible subjects total 119 at 3M	Subjects Using Nasal Sprays for NAO Symptoms Subject using nasal sprays at baseline for the relief of NAO symptoms
Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis	57 score on a scale Standard Error 2.8213	—

Adverse Events

Vivaer Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Vivaer Treatment n=122 participants at risk Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Infections and infestations Events Leading to Death	0.82% 1/122 • Number of events 1 • 2 years
Gastrointestinal disorders Abdominal Pain	0.82% 1/122 • Number of events 1 • 2 years
Eye disorders Corneal Damage	0.82% 1/122 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Worsening Nasal Airway Obstruction	0.82% 1/122 • Number of events 2 • 2 years
Psychiatric disorders Psychiatric Disorder	0.82% 1/122 • Number of events 2 • 2 years
Musculoskeletal and connective tissue disorders Ankle Break	0.82% 1/122 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders pulmonary Alveolar Protenosis	0.82% 1/122 • Number of events 1 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.82% 1/122 • Number of events 1 • 2 years
Nervous system disorders Carpal Tunnel Syndrome	0.82% 1/122 • Number of events 1 • 2 years
Cardiac disorders Aortic Stenosis	0.82% 1/122 • Number of events 1 • 2 years
Nervous system disorders Ischemic Attack	0.82% 1/122 • Number of events 1 • 2 years
Renal and urinary disorders Urinary Tract Infection	0.82% 1/122 • Number of events 1 • 2 years
Cardiac disorders Hypertension	0.82% 1/122 • Number of events 1 • 2 years
Infections and infestations Upper Respiratory Infection	0.82% 1/122 • Number of events 1 • 2 years
Renal and urinary disorders Acute Kidney Injury	0.82% 1/122 • Number of events 1 • 2 years
Infections and infestations Bacteremia	0.82% 1/122 • Number of events 1 • 2 years
Blood and lymphatic system disorders Iron Deficiency Anemia	0.82% 1/122 • Number of events 1 • 2 years
Blood and lymphatic system disorders Hyponatremia	0.82% 1/122 • Number of events 1 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Operations

Aerin Medical

Phone: 650-518-9624

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60