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

Nasal Obstruction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290300
• Other study ID #: TP465
• Status: Completed
• Start date: October 30, 2017
• Est. completion date: July 9, 2022

Study information

• Verified date: February 2024
• Source: Aerin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 9, 2022
• Est. primary completion date: July 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Received nasal obstruction treatment in Aerin Study TP 258

Exclusion Criteria:

• Unwilling to participate in this long-term study

Related Conditions & MeSH terms

• Airway Obstruction
• Nasal Obstruction

Intervention

Device:
• Vivaer Stylus
Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus

Locations

Country	Name	City	State
United States	ENT and Allergy Associates, LLP	Bayside	New York
United States	Colorado ENT and Allergy	Colorado Springs	Colorado
United States	Central California Clinical Research	Fresno	California
United States	Ear, Nose and Throat Associates of Texas	McKinney	Texas
United States	ENT and Allergy Associates, LLP	Middletown	New York
United States	ENT and Allergy Associates, LLP	New Hyde Park	New York
United States	ENT and Allergy Associates, LLP	Oradell	New Jersey
United States	Piedmont Ear, Nose and Throat Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aerin Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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