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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04684875

Enrollment

Registered

2020-12-28

Start date

2020-11-19

Completion date

2022-01-01

Last updated

2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinitis

Keywords

Chronic rhinitis, Posterior nasal nerve, Quality of life

Brief summary

Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the Aerin InSeca/RhinAer Stylus

Detailed description

This is a prospective, non-randomized, multicenter follow-up study to collect long-term data on a cohort of patients who participated in the Aerin Medical TP668 study, Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis. The study will be conducted in a maximum of 5 centers that participated and enrolled patients in the TP668 study.

Interventions

DEVICERadiofrequency Stylus

Low power radiofrequency energy delivered to the posterior nasal nerve area

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Received treatment for chronic rhinitis in Aerin Study TP668

Exclusion criteria

* Unwilling to participate in this long-term study

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline rTNSS	24 months	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026