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Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

Primary Purpose

Nasal Obstruction, Bilateral

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vivaer® ARC Stylus
Sponsored by
HNO-Praxis Alte Post
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction, Bilateral focused on measuring nasal obstruction, nasal valve stenosis, nasal valve pathology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

    -

Sites / Locations

  • HNO-Praxis
  • HNO-Praxis Alte Post
  • HNO-ZENTRUM am Kudamm

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Procedure

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 17, 2021
Last Updated
January 15, 2023
Sponsor
HNO-Praxis Alte Post
Collaborators
Aerin Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04717791
Brief Title
Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing
Official Title
Low Temperature Controlled Radiofrequency Intranasal Remodeling Treatment of the Nasal Valve Area. A Multicentric Long-term Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
October 4, 2022 (Actual)
Study Completion Date
October 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HNO-Praxis Alte Post
Collaborators
Aerin Medical

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Bilateral
Keywords
nasal obstruction, nasal valve stenosis, nasal valve pathology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procedure
Arm Type
Other
Arm Description
Subjects will be followed from the Vivaer® treatment date out to 24 months post index procedure.
Intervention Type
Device
Intervention Name(s)
Vivaer® ARC Stylus
Intervention Description
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
Primary Outcome Measure Information:
Title
response rate Nose Score
Description
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.
Time Frame
3 Months, 6, 12 and 24 months
Secondary Outcome Measure Information:
Title
Efficacy measurement using the change in mean NOSE SCORE
Description
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.
Time Frame
3 Months, 6, 12 and 24 months
Title
Safety Control regarding
Description
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.
Time Frame
3 Months, 6, 12 and 24 months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Incidence (type and category) of adverse events overall and by follow-up interval.
Time Frame
3 Months, 6, 12 and 24 months
Title
Nasal Assessment
Description
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.
Time Frame
3 Months, 6, 12 and 24 months
Title
Medications
Description
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.
Time Frame
3 Months, 6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Prior surgical treatment of the nasal valve Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six months Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk. Known or suspected to be pregnant or is lactating. Any adjunctive surgical nasal procedure planned on the same day or within 24 months after the Vivaer procedure. Current participation in any study or participation in any study less than 6 weeks before study date 1. -
Facility Information:
Facility Name
HNO-Praxis
City
Lichtenfels
State/Province
Bayern
ZIP/Postal Code
96215
Country
Germany
Facility Name
HNO-Praxis Alte Post
City
Göttingen
State/Province
Niedersachen
ZIP/Postal Code
37073
Country
Germany
Facility Name
HNO-ZENTRUM am Kudamm
City
Berlin
ZIP/Postal Code
10629
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

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