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

NCT03290300 | Completed Results

• 1 other identifier: TP465
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Nasal Obstruction

Keywords

Nasal valve; Nasal airway obstruction; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  12, 18, 24 months post-procedure

Study Arms (1)

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.

Device: Vivaer Stylus

Interventions

Vivaer Stylus DEVICE

Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus

Also known as: Aerin Medical Device

Long-Term Study Subjects

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Received nasal obstruction treatment in Aerin Study TP 258

You may not qualify if:

• Unwilling to participate in this long-term study

Sponsors & Collaborators

• Aerin Medical: lead

Study Sites (8)

Central California Clinical Research

Fresno, California, 93720, United States

Location

Colorado ENT and Allergy

Colorado Springs, Colorado, 80909, United States

Location

ENT and Allergy Associates, LLP

Oradell, New Jersey, 07649, United States

Location

ENT and Allergy Associates, LLP

Bayside, New York, 11360, United States

Location

ENT and Allergy Associates, LLP

Middletown, New York, 10941, United States

Location

ENT and Allergy Associates, LLP

New Hyde Park, New York, 11042, United States

Location

Piedmont Ear, Nose and Throat Associates

Winston-Salem, North Carolina, 27103, United States

Location

Ear, Nose and Throat Associates of Texas

McKinney, Texas, 75070, United States

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Scott Wolf, M.D.; Chief Medical Officer
• Organization: Aerin Medical, Inc.

swolf@aerinmedical.com

650-597-0111

Study Officials

• Scott Wolf, MD

  Aerin Medical

  STUDY DIRECTOR

• Ofer Jacobowitz, MD, PhD

  ENT and Allergy Associates, Middletown, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: October 30, 2017
• Primary Completion: July 9, 2022
• Study Completion: July 9, 2022
• Last Updated: February 15, 2024
• Results First Posted: August 19, 2019

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)