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Completed

NCT Number: NCT04684875

Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device

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

Completed

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Key information

Conditions

Chronic Rhinitis

Age range

22 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Colorado ENT and Allergy, Colorado Springs, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Received treatment for chronic rhinitis in Aerin Study TP668

Exclusion criteria

  • Unwilling to participate in this long-term study

Treatment and study plan

Radiofrequency Stylus

Device

Low power radiofrequency energy delivered to the posterior nasal nerve area

Other names: Aerin Medical Device, InSeca Stylus, RhinAer Stylus

Primary outcomes

  1. Change from Baseline rTNSS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 28, 2020
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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