Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

Low Temperature Controlled Radiofrequency Intranasal Remodeling Treatment of the Nasal Valve Area. A Multicentric Long-term Evaluation

A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction

Study Overview

• Status: Completed
• Conditions: Nasal Obstruction, Bilateral
• Intervention / Treatment: Device: Vivaer® ARC Stylus

Detailed Description

The primary objective of this post-market study is 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 using validated questionaires.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10629
    • HNO-ZENTRUM am Kudamm
  • Bayern
    • Lichtenfels, Bayern, Germany, 96215
      • HNO-Praxis
  • Niedersachen
    • Göttingen, Niedersachen, Germany, 37073
      • HNO-Praxis Alte Post

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Eligible subject will meet all the following:

• 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:

Eligible subjects will NOT meet any of the following:

1. Prior surgical treatment of the nasal valve
2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six months
3. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
4. Known or suspected to be pregnant or is lactating.
5. Any adjunctive surgical nasal procedure planned on the same day or within 24 months after the Vivaer procedure.

6. Current participation in any study or participation in any study less than 6 weeks before study date 1.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Procedure; Subjects will be followed from the Vivaer® treatment date out to 24 months post index procedure.

Device: Vivaer® ARC Stylus; The Vivaer procedure will be performed in the study clinic using the VivAer Stylus and Aerin Console. The VivAer Stylus is a disposable handheld device capable of delivering low-temperature bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nasal valves treated in a single study procedure session. Each nostril will be treated at up to 3 positions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response rate Nose Score	The primary efficacy endpoint is the responder rate at 3 months after the procedure for the participants. Individual participant success (responder) is defined as at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class improvement or an improvement (decrease) in NOSE score of 20% or more from baseline at the 3-month evaluation.	3 Months, 6, 12 and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy measurement using the change in mean NOSE SCORE	Efficacy measurement using the change in mean NOSE SCORE from baseline to the 3-month evaluation. The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity.	3 Months, 6, 12 and 24 months
Safety Control regarding	Safety Control regarding the frequency of device-related and procedure-related adverse events. All adverse events will be analyzed for all participants. Adverse events will be coded using a custom Aerin Medical dictionary so that adverse events may be categorized for analysis at an appropriate level of detail. Listings will be provided to detail individual events. The number of participants, number of AEs, and the proportion of participants reporting each AE will be summarized. Seriousness and severity of AEs and their relationship to the device and procedure will be summarized. A time course of adverse events will be presented. Any unexpected adverse device experiences or adverse events that occur at an unexpectedly high incidence rate will receive detailed analyses. Narratives will be presented for all deaths, serious adverse events, unexpected adverse device experiences, and participants withdrawn due to an adverse event.	3 Months, 6, 12 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Incidence (type and category) of adverse events overall and by follow-up interval.	3 Months, 6, 12 and 24 months
Nasal Assessment	The target nasal valve area within each nostril will be visually assessed at baseline and following the treatment procedure at all evaluations. The use of an endoscope for visual assessment is required. Representative still photographs or video of each nostril will be captured at each visit.	3 Months, 6, 12 and 24 months
Medications	Self-reported assessment of an increase, no change, or decrease in medications and/or devices being used for treatment of nasal symptoms at each evaluation compared to use prior to the procedure.	3 Months, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: HNO-Praxis Alte Post
• Collaborators: Aerin Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): October 4, 2022
• Study Completion (Actual): October 4, 2022

Study Registration Dates

• First Submitted: January 17, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: nasal obstruction; nasal valve stenosis; nasal valve pathology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: RFNV001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No