Vivaer Procedure for Nasal Airway Obstruction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nasal Airway Obstruction+2 More
Vivaer ARC Stylus - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the Vivaer procedure, which uses RF energy to treat NAO, to a sham procedure.

Eligible Conditions
  • Nasal Airway Obstruction

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 3 months visit following the study procedure.

Month 3
Nasal Obstruction Symptom Evaluation (NOSE) Scale Responder Rate
Month 3
Therapeutic procedure
Month 3
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Vivaer Procedure
1 of 2
Sham Control Procedure
1 of 2

Active Control

Non-Treatment Group

119 Total Participants · 2 Treatment Groups

Primary Treatment: Vivaer Procedure · Has Placebo Group · N/A

Vivaer Procedure
Device
ActiveComparator Group · 1 Intervention: Vivaer ARC Stylus · Intervention Types: Device
Sham Control Procedure
Device
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months visit following the study procedure.

Who is running the clinical trial?

Aerin MedicalLead Sponsor
11 Previous Clinical Trials
810 Total Patients Enrolled
1 Trials studying Nasal Airway Obstruction
33 Patients Enrolled for Nasal Airway Obstruction
Joseph Han, MDPrincipal InvestigatorEVMS Medical Group
Stacey Silvers, MDPrincipal InvestigatorMadison ENT

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a nasal valve that is open to the outside.
The examiner can feel the nasal valve opening.\n
You have a baseline NOSE score ≥ 55.
You use external nasal dilator strips (eg, Breathe Right Strips) to help you breathe through your nose.
You are willing and able to comply with the requirements of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: November 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%