Nasal ObstructionNCT03290300

Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device

An observational study of Nasal Obstruction, run by Aerin Medical at 8 sites in United States.

Completed

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

Trial summary

Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Nasal Obstruction
What is being tested?: Vivaer Stylus
Type of treatment: Medical device
How many people: 39 participants
Where: 8 sitesUnited States
Study dates: 30 Oct 2017to 9 Jul 2022
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The subjects in this study will all have completed participation in the TP 258 Nasal Obstruction study.

Who may be able to join

Received nasal obstruction treatment in Aerin Study TP 258

Who cannot join

Unwilling to participate in this long-term study

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 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
Middletown, New York, 10941
ENT and Allergy Associates, LLP
New Hyde Park, New York, 11042
ENT and Allergy Associates, LLP
Oradell, New Jersey, 07649
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 the Quality of Life Impact After Treatment of Nasal Airway Obstruction Using the Aerin Medical Vivaer Stylus

Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus

Read the detailed description

This is a prospective, non-randomized, multi-center follow-up study to collect long term quality of life (QOL) data on a cohort of patients who participated in the Aerin Medical TP258 study "A Prospective, Multi-Center, Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device". The TP258 study followed subjects out to 26 weeks post-procedure. This QOL study will collect data at 12, 18, 24, 36, 48 and 60 months post-procedure.

Conditions: Nasal Obstruction
Being tested: Vivaer Stylus
Keywords: Nasal valve, Nasal airway obstruction, Quality of Life
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
Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus

Study groups in NCT03290300
Study group	Role	What they receive
Long-Term Study Subjects		This cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data. Receives: Device: Vivaer Stylus

What is being measured

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

Change From Baseline NOSE Score
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.
Measured: Baseline, 12, 18, 24 months post-procedure
Change From Baseline NOSE Score - Long Term Extended Follow-up
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.
Measured: Update to include Extended Follow up to 36-, 48- months post-procedure
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered "agree or agree strongly" when prompted with "Compared to before I had the Aerin Medical Nasal Procedure, I have experienced..." were considered to have a positive response. For questions 15-18, those who answered "rarely/very rarely/never" when prompted with "Compared to before you had the procedure, how often did you suffer from the following conditions?..." were considered to have a positive response. For questions 19-21, those who answered "less or much less frequently" when prompted with "Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?..." were considered to have a positive response.
Measured: 12, 18, 24 months post-procedure

Timeline

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

30 Oct 20179 Jul 2022

First posted21 Sep 2017
Study start30 Oct 2017
Primary completion9 Jul 2022
Study completion9 Jul 2022

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03290300
Sponsor's protocol ID: TP465
Status last verified: Feb 2024
First submitted: 19 Sep 2017
Last updated: 15 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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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Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
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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
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Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
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Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
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All Nasal Obstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center, Non-Randomized Study to Evaluate the Quality of Life Impact After Treatment of Nasal Airway Obstruction Using the Aerin Medical Vivaer Stylus
ClinicalTrials.gov ID: NCT03290300
Acronym / sponsor ID: TP465
Conditions: Nasal Obstruction
Keywords: Nasal valve, Nasal airway obstruction, Quality of Life
Study type: Observational
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Aerin MedicalIndustry (pharma, biotech, devices)
Study start: 30 Oct 2017 (actual)
Primary completion: 9 Jul 2022 (actual)
Study completion: 9 Jul 2022 (actual)
First posted: 21 Sep 2017 (actual)
Results: Posted 19 Aug 2019

Clinical summary

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

Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Long-Term Study Subjects	–	Device: Vivaer StylusThis cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The subjects in this study will all have completed participation in the TP 258 Nasal Obstruction study.

Key inclusion criteria (1 listed)

Received nasal obstruction treatment in Aerin Study TP 258

Key exclusion criteria (1 listed)

Unwilling to participate in this long-term study

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 DevicePrevious nasal obstruction treatment with the Aerin Medical Vivaer Stylus	Device	Long-Term Study Subjects

Primary outcome

Change From Baseline NOSE Score
Time frame: Baseline, 12, 18, 24 months post-procedure
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.
Change From Baseline NOSE Score - Long Term Extended Follow-up
Time frame: Update to include Extended Follow up to 36-, 48- months post-procedure
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Time frame: 12, 18, 24 months post-procedure
This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered "agree or agree strongly" when prompted with "Compared to before I had the Aerin Medical Nasal Procedure, I have experienced..." were considered to have a positive response. For questions 15-18, those who answered "rarely/very rarely/never" when prompted with "Compared to before you had the procedure, how often did you suffer from the following conditions?..." were considered to have a positive response. For questions 19-21, those who answered "less or much less frequently" when prompted with "Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?..." were considered to have a positive response.

Results and safety

Results posted to the registry on 19 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Long-Term Study Subjects	39	36

Primary outcome: Change From Baseline NOSE Score

Time frame: Baseline, 12, 18, 24 months post-procedure. Mean (Standard Deviation). Unit: units on a scale

Measure	Long-Term Study Subjects - 12 Month Data n = 36	Long-Term Study Subjects - 18 Month Data n = 39	Long-Term Study Subjects - 24 Month Data n = 36
Value	53.3 (25.2)	48.1 (30.2)	53.5 (24.6)

Long-Term Study Subjects - 12 Month Data vs Long-Term Study Subjects - 18 Month Data vs Long-Term Study Subjects - 24 Month Data: p <0.0001, ANOVA

Population analysed: The population evaluated at 12 months was 36, rather than the full 39 participants, since 3 subjects had not completed the consent process until after the 12-month post-procedure evaluation window. By the 24-month follow-up, 3 subjects had been lost to follow-up.

Primary outcome: Change From Baseline NOSE Score - Long Term Extended Follow-up

Time frame: Update to include Extended Follow up to 36-, 48- months post-procedure. Mean (Standard Deviation). Unit: score on a scale

Measure	36 Month n = 28	Long-Term Study Subjects - 48 Month Data n = 28
Value	32.3 (21.4)	25.7 (19.1)

Population analysed: Of the 49 patients in the initial study,39 agreed to participate in follow-up through 24 months.

Primary outcome: Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items

Time frame: 12, 18, 24 months post-procedure. Count of participants. Unit: Participants

Measure	Long-Term Study Subjects - 12 Month n = 36	Long-Term Study Subjects - 18 Month Data n = 39	Long-Term Study Subjects - 24 Month Data n = 36
Q1: Less difficulty falling asleep	25	22	28
Q2: Less waking up at night	20	25	25
Q3: Better sleep throughout the night	23	27	26
Q4: Waking up feeling rested	18	21	22
Q5: Less fatigue during the day	20	24	19
Q6: Increased productivity	13	16	21
Q7: Increased energy	18	16	22
Q8: Increased ability to focus	11	18	22

Population analysed: Data missing for some questions not answered by subjects.

Adverse events

Time frame: Between 1 and 2 years post-procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Long-Term Study Subjects	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Limitations and caveats (from the sponsor): use of a single-arm design without randomized control, no control of medication usage, and significant patient attrition relative to the primary study. Two nonparticipants were known to have undergone subsequent surgery for nasal obstruction and it is possible that the effectiveness declined in the extended follow-up nonparticipants, although participants and non-participants had similar baseline characteristics and both groups experienced robust NOSE score reductions at 6months.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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.
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Recruiting
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
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Recruiting
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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

ENT and Allergy Associates, Middletown, NY

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

Questions about this trial

What is this clinical trial studying?

An observational study of Nasal Obstruction, run by Aerin Medical at 8 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 1 inclusion and 1 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 19 Aug 2019). 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?

Change From Baseline NOSE Score (time frame: Baseline, 12, 18, 24 months post-procedure). The study lists 3 primary outcomes in all. 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 NCT03290300.

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 15 Feb 2024.