Nasal ObstructionNCT02914236

Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

A study testing Vivaer Stylus in people with Nasal Obstruction, run by Aerin Medical at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction. Read more about this study

Who is it for?: Ages 22 to 75 years
Conditions the study is for: Nasal Obstruction
What is being tested?: Vivaer Stylus
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 9 sitesUnited States
Study dates: 27 Sep 2016to 18 Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Seeking treatment for nasal obstruction and willing to undergo an office-based procedure
Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at Baseline
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)

Who cannot join

Prior surgical treatment of the nasal valve
Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past twelve (12) months
Chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction
Septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a significant contributor to the subject's nasal obstruction symptoms
Known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications
Known or suspected to be pregnant, or is lactating
Other medical conditions which in the opinion of the investigator could predispose the subject to poor wound healing or increased surgical risk

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

ENT and Allergy Associates, LLP
Bayside, New York, 11360
Colorado ENT and Allergy
Colorado Springs, Colorado, 80909
Central California Clinical Research
Fresno, California, 93720
Ear, Nose and Throat Associates of Texas
McKinney, Texas, 75070
ENT and Allergy Associates, LLP
New Hyde Park, New York, 11042
ENT and Allergy Associates, LLP
New York, New York, 10017
ENT and Allergy Associates, LLP
Oradell, New Jersey, 07649
ENT and Allergy Associates, LLP
Staten Island, New York, 10314
Piedmont Ear, Nose and Throat Associates
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.

Read the detailed description

This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (Vivaer Stylus) when used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Conditions: Nasal Obstruction
Being tested: Vivaer Stylus
Keywords: Nasal valve, Nasal airway obstruction
Medical subject headings: Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vivaer StylusDevice
Also called Aerin Medical Device
Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area

Study groups in NCT02914236
Study group	Role	What they receive
Vivaer Stylus	Experimental	Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Receives: Device: Vivaer Stylus

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement in NOSE Score
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive value.
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.
Measured: Baseline, 26 weeks

Secondary outcomes (2)

NOSE Responder Rate
Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment.
Measured: Baseline, 26 weeks
Percentage of Participants With Treatment-Related Adverse Events (Safety)
Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.
Measured: Baseline through 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 201618 Aug 2017

First posted26 Sep 2016 (estimated)
Study start27 Sep 2016
Primary completion21 Jul 2017
Study completion18 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nasal ObstructionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02914236
Sponsor's protocol ID: TP258
Status last verified: May 2019
First submitted: 22 Sep 2016
Last updated: 21 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Influence of Patient Positioning During Nasal Lavage
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Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Recruiting
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
Nasal Airway Obstruction
Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Nasal Obstruction Due to Inferior Turbinate Hypertrophy

All Nasal Obstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
ClinicalTrials.gov ID: NCT02914236
Acronym / sponsor ID: TP258
Conditions: Nasal Obstruction
Keywords: Nasal valve, Nasal airway obstruction
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Aerin MedicalIndustry (pharma, biotech, devices)
Study start: 27 Sep 2016 (actual)
Primary completion: 21 Jul 2017 (actual)
Study completion: 18 Aug 2017 (actual)
First posted: 26 Sep 2016 (estimated)
Results: Posted 6 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vivaer Stylus	Experimental	Device: Vivaer StylusIntervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area

Who may qualify

Ages: 22 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Seeking treatment for nasal obstruction and willing to undergo an office-based procedure
Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at Baseline
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)

Key exclusion criteria (7 listed)

Prior surgical treatment of the nasal valve
Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past twelve (12) months
Chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction
Septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a significant contributor to the subject's nasal obstruction symptoms
Known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vivaer StylusAlso: Aerin Medical DeviceDelivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area	Device	Vivaer Stylus

Primary outcome

Improvement in NOSE Score
Time frame: Baseline, 26 weeks
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive value. 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.

2 secondary outcomes

NOSE Responder Rate
Time frame: Baseline, 26 weeks
Percentage of Participants With Treatment-Related Adverse Events (Safety)
Time frame: Baseline through 26 weeks

Results and safety

Results posted to the registry on 6 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vivaer Stylus	50	49

Primary outcome: Improvement in NOSE Score

Time frame: Baseline, 26 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Vivaer Stylus n = 49
Value	54.8 (21.9)

Vivaer Stylus: p <0.0001, t-test, 2 sided

Population analysed: Does not include subject lost-to-follow-up prior to the 26-week follow-up visit

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From procedure through 26-week follow-up visit. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vivaer Stylus	2 of 50 (4%)	18 of 50 (36%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Nasal Obstruction

Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Recruiting
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
Nasal Airway Obstruction
Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Nasal Obstruction Due to Inferior Turbinate Hypertrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott Wolf, MD study director

Aerin Medical

Ofer Jacobowitz, MD, PhD principal investigator

Mount Sinai Hospital, New York, NY

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vivaer Stylus in people with Nasal Obstruction, run by Aerin Medical at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in NOSE Score (time frame: Baseline, 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02914236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.