Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

NCT ID: NCT04717791

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2022-10-04

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.

Conditions

Nasal Obstruction, Bilateral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Procedure

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

Group Type: OTHER

Vivaer® ARC Stylus

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerin Medical

INDUSTRY

Sponsor Role: collaborator

HNO-Praxis Alte Post

OTHER

Sponsor Role: lead

Responsible Party

Professor Dr. med. Detlef Brehmer

PI Prof. Dr. med. Detlef Brehmer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

HNO-Praxis

Lichtenfels, Bavaria, Germany

HNO-Praxis Alte Post

Göttingen, Niedersachen, Germany

HNO-ZENTRUM am Kudamm

Berlin, , Germany

Countries

Germany

Other Identifiers

RFNV001

Identifier Type: -

Identifier Source: org_study_id