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

• ClinicalTrials.gov Identifier: NCT04277507
• Recruitment Status: Active, not recruiting
• First Posted: February 20, 2020
• Results First Posted: May 25, 2023
• Last Update Posted: April 30, 2024
• Sponsor: Aerin Medical
• Information provided by (Responsible Party): Aerin Medical

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Nasal Obstruction
• Intervention: Device: Vivaer Stylus
• Enrollment: 122

Participant Flow

Recruitment Details	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.
Pre-assignment Details

Arm/Group Title	Vivaer Treatment
Arm/Group Description	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.
Period Title: Overall Study
Started	122
Completed	91 [1]
Not Completed	31
Reason Not Completed
Lost to Follow-up	17
Completed through 24M but not interested in extension to 36M	3
Received Treatment Outside of Study that could affect study results	2
Withdrawal by Subject	3
Death due to COVID-19	1
Data missing for full evaluation	5
[1] A total of 122 patients were treated and 91 reached (24M Visit) 2 years. The study is still in follow-up through 36M (3 years).

Baseline Characteristics

Arm/Group Title		Vivaer Treatment
Arm/Group Description		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
Overall Number of Baseline Participants		122
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	122 participants
<60 years		83 68.0%
>=60 years		39 32.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	122 participants
	Female	64 52.5%
	Male	58 47.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	122 participants
White		107 87.7%
Black or African American		4 3.3%
Asian		3 2.5%
Asian, White		2 1.6%
Black or African American, White		1 0.8%
Declined Available Choices		5 4.1%
Baseline NOSE Scale Score [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	122 participants
		80.3 (12.6)
		[1] Measure Description: Nasal Obstruction Symptom Evaluation Scale (NOSE scale). Subject completed 1 month review of the following 5 categories: Nasal Congestion/Stuffiness; Nasal Blockage or Obstruction; Trouble Breathing through my nose; Trouble Sleeping/ Unable to get enough air through my nose during exercise or exertion. Subjects answer 0-4 (0=not a problem; 1=very mild problem; 2=moderate problem; 3fairly bad problem; 4=severe problem) answers are multiplied by 5, score is out of 100
Body Mass Index [1]; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	122 participants
		27.6 (6.7)
		[1] Measure Description: Average Body Mass Index across all subjects
Nasal Valve Collapse Mechanism; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	122 participants
Bilateral Dynamic		68 55.7%
Bilateral Static		47 38.5%
Unilateral Dynamic		2 1.6%
Unilateral Dynamic and Unilateral Static		2 1.6%
Unilateral Static		1 0.8%
Unreported		2 1.6%
Additional Nasal Obstruction Diagnosis; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	122 participants
Nasal Valve Stenosis		64 52.5%
Septal Turbinate (Nasal Septal Body)		37 30.3%
Septal Deviation		34 27.9%
Turbinate Enlargement		31 25.4%
Nasal Polyps		3 2.5%
History of Nasal Surgery; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	122 participants
		67 54.9%

Outcome Measures

1. Primary Outcome

Title	Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months
Description	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.
Time Frame	3 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Protocol Eligible Subjects
Arm/Group Description:	Scores per-protocol eligible subjects total 119 at 3M
Overall Number of Participants Analyzed	119
Mean (Standard Error); Unit of Measure: score on a scale
	-47.6 (26.1)

2. Other Pre-specified Outcome

Title	Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure
Description	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.
Time Frame	3 months post study procedure

Outcome Measure Data

Analysis Population Description

All treated subjects VAS score at 3 months post procedure

Arm/Group Title	Vivaer Treatment
Arm/Group Description:	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
Overall Number of Participants Analyzed	122
Mean (Standard Deviation); Unit of Measure: millimeters
	4.5 (8.8)

3. Other Pre-specified Outcome

Title	Subject Reported Change in Medication Use for Nasal Obstruction Symptoms
Description	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
Time Frame	24 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Taking Oral Medications at Baseline for NAO Symptoms	Subjects Using Nasal Sprays for NAO Symptoms
Arm/Group Description:	Subjects using Oral Medications at baseline for the relief of NAO Symptoms	Subject using nasal sprays at baseline for the relief of NAO symptoms
Overall Number of Participants Analyzed	63	66
Measure Type: Count of Participants; Unit of Measure: Participants
	31 49.2%	34 51.5%

4. Other Pre-specified Outcome

Title	Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis
Description	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
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Analysis Cohort (24)M (Vivaer Treatment)
Arm/Group Description:	89 Eligible subjects who completed through 24 month visit with 12 excluded for anyaisis
Overall Number of Participants Analyzed	89
Mean (Standard Error); Unit of Measure: score on a scale
	57 (2.8213)

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Vivaer Treatment
Arm/Group Description	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
All-Cause Mortality
	Vivaer Treatment
	Affected / at Risk (%)
Total	1/122 (0.82%)
Serious Adverse Events
	Vivaer Treatment
	Affected / at Risk (%)	# Events
Total	1/122 (0.82%)
Blood and lymphatic system disorders
Iron Deficiency Anemia *	1/122 (0.82%)	1
Hyponatremia *	1/122 (0.82%)	1
Cardiac disorders
Aortic Stenosis *	1/122 (0.82%)	1
Hypertension *	1/122 (0.82%)	1
Eye disorders
Corneal Damage *	1/122 (0.82%)	1
Gastrointestinal disorders
Abdominal Pain * [1]	1/122 (0.82%)	1
Infections and infestations
Events Leading to Death * [2]	1/122 (0.82%)	1
Upper Respiratory Infection *	1/122 (0.82%)	1
Bacteremia *	1/122 (0.82%)	1
Musculoskeletal and connective tissue disorders
Ankle Break *	1/122 (0.82%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer *	1/122 (0.82%)	1
Nervous system disorders
Carpal Tunnel Syndrome *	1/122 (0.82%)	1
Ischemic Attack *	1/122 (0.82%)	1
Psychiatric disorders
Psychiatric Disorder *	1/122 (0.82%)	2
Renal and urinary disorders
Urinary Tract Infection *	1/122 (0.82%)	1
Acute Kidney Injury *	1/122 (0.82%)	1
Respiratory, thoracic and mediastinal disorders
Worsening Nasal Airway Obstruction *	1/122 (0.82%)	2
pulmonary Alveolar Protenosis *	1/122 (0.82%)	1
* Indicates events were collected by non-systematic assessment; [1] Severe Abdominal Pain; [2] COVID-19
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Vivaer Treatment
	Affected / at Risk (%)	# Events
Total	0/122 (0.00%)

Limitations and Caveats

Limitations of this study are its lack of a control arm and the non-blinded nature of this study

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Director of Clinical Operations
• Organization: Aerin Medical
• Phone: 650-518-9624
• EMail: alaborde@aerinmedical.com

Publications of Results:

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/lio2.1089. eCollection 2023 Aug.

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

• Responsible Party: Aerin Medical
• ClinicalTrials.gov Identifier: NCT04277507
• Other Study ID Numbers: TP900
• First Submitted: February 17, 2020
• First Posted: February 20, 2020
• Results First Submitted: January 30, 2023
• Results First Posted: May 25, 2023
• Last Update Posted: April 30, 2024