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

Completed

Conditions: Nasal Obstruction

Interventions: Device: Vivaer Stylus

Registration Number: NCT03290300

Lead Sponsor: Aerin Medical

Brief Summary: Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

Inclusion Criteria

Received nasal obstruction treatment in Aerin Study TP 258

Exclusion Criteria

Unwilling to participate in this long-term study

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Long-Term Study Subjects	Vivaer Stylus	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.

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items	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.
Change From Baseline NOSE Score - Long Term Extended Follow-up	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.
Change From Baseline NOSE Score	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (5): Ear, Nose and Throat Associates of Texas
🇺🇸
McKinney, Texas, United States
Piedmont Ear, Nose and Throat Associates
🇺🇸
Winston-Salem, North Carolina, United States
Colorado ENT and Allergy
🇺🇸
Colorado Springs, Colorado, United States
ENT and Allergy Associates, LLP
🇺🇸
New Hyde Park, New York, United States
Central California Clinical Research
🇺🇸
Fresno, California, United States