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

Completed
Conditions
Nasal Obstruction
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
Primary Outcome Measures
NameTimeMethod
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items12, 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-upUpdate 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 ScoreBaseline, 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
NameTimeMethod

Trial Locations

Locations (5)

Central California Clinical Research

🇺🇸

Fresno, California, United States

Colorado ENT and Allergy

🇺🇸

Colorado Springs, Colorado, United States

ENT and Allergy Associates, LLP

🇺🇸

New Hyde Park, New York, United States

Piedmont Ear, Nose and Throat Associates

🇺🇸

Winston-Salem, North Carolina, United States

Ear, Nose and Throat Associates of Texas

🇺🇸

McKinney, Texas, United States

Central California Clinical Research
🇺🇸Fresno, California, United States

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