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

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

Study Overview

• Status: Completed
• Conditions: Nasal Obstruction
• Intervention / Treatment: Device: Vivaer Stylus

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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Central California Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Colorado ENT and Allergy
  • New Jersey
    • Oradell, New Jersey, United States, 07649
      • ENT and Allergy Associates, LLP
  • New York
    • Bayside, New York, United States, 11360
      • ENT and Allergy Associates, LLP
    • Middletown, New York, United States, 10941
      • ENT and Allergy Associates, LLP
    • New Hyde Park, New York, United States, 11042
      • ENT and Allergy Associates, LLP
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Ear, Nose and Throat Associates
  • Texas
    • McKinney, Texas, United States, 75070
      • Ear, Nose and Throat Associates of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Received nasal obstruction treatment in Aerin Study TP 258

Exclusion Criteria:

• Unwilling to participate in this long-term study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus; Other Names: Aerin Medical Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aerin Medical
• Investigators: Study Director: Scott Wolf, MD, Aerin Medical; Principal Investigator: Ofer Jacobowitz, MD, PhD, ENT and Allergy Associates, Middletown, NY

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): July 9, 2022
• Study Completion (Actual): July 9, 2022

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Nasal airway obstruction; Nasal valve
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: TP465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No