CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 116 enrolled
Drug / intervention
RhinAer Stylus +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04533438
NCT04533438N/ACompleted
CompareCT.gov

The RhinAer Procedure for Treatment of CHronic RhInitis - A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control (RHINTRAC)

Aerin Medical·interventional·Posted Aug 31, 2020·Updated May 2, 2025

In Brief

A clinical study evaluating RhinAer Stylus and Sham for Chronic Rhinitis. Completed, enrolled 116 participants across 13 sites.

Detailed Summary

The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Rhinitis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 31, 2020
Enrollment StartJul 31, 2020
Primary CompletionApr 9, 2021
Study CompletionDec 30, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.8 years ago

Interventions

RhinAer Stylusdevice

The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session.

Shamdevice

The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).