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

Chronic Rhinitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684875
• Other study ID #: CTP1078
• Status: Completed
• Start date: November 19, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2023
• Source: Aerin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 1, 2022
• Est. primary completion date: July 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 99 Years

Eligibility

Inclusion Criteria:

• Received treatment for chronic rhinitis in Aerin Study TP668

Exclusion Criteria:

• Unwilling to participate in this long-term study

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

Device:
• Radiofrequency Stylus
Low power radiofrequency energy delivered to the posterior nasal nerve area

Locations

Country	Name	City	State
United States	Colorado ENT and Allergy	Colorado Springs	Colorado
United States	Fort Worth ENT	Fort Worth	Texas
United States	ENT and Allergy Associates of Texas	McKinney	Texas
United States	Advanced ENT and Allergy	New Albany	Indiana
United States	Piedmont ENT 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 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