Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

Not Applicable

Completed

• Conditions: Nasal Obstruction, Bilateral
• Interventions: Device: Vivaer® ARC Stylus

• Registration Number: NCT04717791
• Lead Sponsor: HNO-Praxis Alte Post

Brief Summary

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

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 Timeline

• Study Start: 2020-09-08
• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Primary Completion: 2022-10-04
• Study Completion: 2022-10-04
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-15
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procedure	Vivaer® ARC Stylus	Subjects will be followed from the Vivaer® treatment date out to 24 months post index procedure.

Primary Outcome Measures

Name	Time	Method
response rate Nose Score	3 Months, 6, 12 and 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy measurement using the change in mean NOSE SCORE	3 Months, 6, 12 and 24 months	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.
Safety Control regarding	3 Months, 6, 12 and 24 months	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.

Trial Locations

Locations (3)

HNO-Praxis; 🇩🇪 Lichtenfels, Bayern, Germany

HNO-Praxis Alte Post; 🇩🇪 Göttingen, Niedersachen, Germany

HNO-ZENTRUM am Kudamm; 🇩🇪 Berlin, Germany