Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device
A Prospective, Multi-center, Non-Randomized Study to Evaluate the Quality of Life Impact and Symptoms After Treatment Using Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis
1 other identifier
observational
45
1 country
5
Brief Summary
Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the Aerin InSeca/RhinAer Stylus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 19, 2020
CompletedFirst Submitted
Initial submission to the registry
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
December 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedApril 18, 2023
April 1, 2023
8 months
December 22, 2020
April 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline rTNSS
Mean change in reflective Total Nasal Symptom Score (rTNSS) from baseline. The TNSS is an instrument used to collect patient self-rated severity of rhinorrhea, nasal congestion, nasal itching and sneezing. In this study, a reflective score will be collected, in which the subject will be asked to evaluate symptom severity over the preceding 12 hours. Symptom severity is rated on a 4-point scale of 0 (absent symptoms), 1 (mild symptoms), 2 (moderate symptoms, or 3 (severe symptoms), with the total score therefore ranging from 0 to 12. A negative change reported for the change from baseline indicates an improved outcome.
24 months
Study Arms (1)
Long-Term Study Subjects
All subjects who were treated with the Aerin Medical InSeca/RhinAer Stylus in the 50-subject TP668 interventional study, who consent to continue to provide quality of life data.
Interventions
Low power radiofrequency energy delivered to the posterior nasal nerve area
Eligibility Criteria
Subjects who completed the 52-week follow-up visit of Aerin Study TP668 and consent to provide long-term quality of life and symptom information.
You may qualify if:
- Received treatment for chronic rhinitis in Aerin Study TP668
You may not qualify if:
- Unwilling to participate in this long-term study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aerin Medicallead
Study Sites (5)
Colorado ENT and Allergy
Colorado Springs, Colorado, 80909, United States
Advanced ENT and Allergy
New Albany, Indiana, 47150, United States
Piedmont ENT Associates
Winston-Salem, North Carolina, 27103, United States
Fort Worth ENT
Fort Worth, Texas, 76109, United States
ENT and Allergy Associates of Texas
McKinney, Texas, 75070, United States
Study Officials
- STUDY DIRECTOR
Scott Wolf, MD
Aerin Medical, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2020
First Posted
December 28, 2020
Study Start
November 19, 2020
Primary Completion
July 25, 2021
Study Completion
January 1, 2022
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share