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

Tracking Information

• First Submitted Date: February 17, 2020
• First Posted Date: February 20, 2020
• Results First Submitted Date: January 30, 2023
• Results First Posted Date: May 25, 2023
• Last Update Posted Date: April 30, 2024
• Actual Study Start Date: February 7, 2020
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2023)

Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months [ Time Frame: 3 Month ]

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.

Original Primary Outcome Measures (submitted: February 18, 2020)

• Improvement in Nasal Obstructive Symptom Evaluation (NOSE) Scores [ Time Frame: Baseline, 3 months, 6 months, 12 months and 24 months post study procedure ]
  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 severe nasal obstructive symptoms.
• Improvement in symptoms as documented by the subject in the Quality of Life (QOL) Questionnaire. [ Time Frame: 3 months, 6 months, 12 months and 24 months post study procedure ]
  Subject self reported study-specific Quality of Life (QOL) Questionnaire - The QOL questionnaire will be used to gain better understanding of the impact of nasal obstruction on the subject's daily activities, feelings, symptoms and medication use. The QOL will be completed by the subject at 3 months, 6 months, 12 months and 24 months post study procedure.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: May 2, 2023)

• Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure [ Time Frame: 3 months post 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.
• Subject Reported Change in Medication Use for Nasal Obstruction Symptoms [ Time Frame: 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
• Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis [ Time Frame: 24 Months ]
  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

Original Other Pre-specified Outcome Measures (submitted: February 18, 2020)

• Subject-reported Visual Analog Scale (VAS) Pain scores in relation to the area treated by the study procedure [ Time Frame: 3 months post study procedure ]
  Visual Analog Scale (VAS) Pain scores will be evaluated at 3 months post study procedure. VAS scores range from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
• Subject reported medication use for nasal obstruction symptoms [ Time Frame: 3 months, 6 months, 12 months and 24 months post study procedure ]
  Evaluate change 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
• Subject reported type and frequency of adverse events [ Time Frame: 3 months, 6 months, 12 months and 24 months post study procedure ]
  Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period

Descriptive Information

• Brief Title: Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction
• Official Title: A Prospective, Multicenter Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)
• Brief Summary: Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
• Detailed 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Nasal Obstruction

Intervention

Device: Vivaer Stylus

Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area

Other Name: Aerin Medical Device

Study Arms

Experimental: Vivaer Stylus

Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area

Intervention: Device: Vivaer Stylus

Publications *

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 30, 2023): 122
• Original Estimated Enrollment (submitted: February 18, 2020): 125
• Estimated Study Completion Date: December 31, 2024
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04277507
• Other Study ID Numbers: TP900
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Aerin Medical
• Original Responsible Party: Same as current
• Current Study Sponsor: Aerin Medical
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Aerin Medical
• Verification Date: April 2024