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N/A

RhinAer ARC Stylus for Chronic Rhinitis (RELIEF Trial)

N/A
Waitlist Available
Research Sponsored by Aerin Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea)
Age 18 to 85 years (inclusively).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months post study procedure
Awards & highlights

RELIEF Trial Summary

This trial will continue to study the effectiveness of the RhinAer ARC Stylus for people with chronic rhinitis.

Who is the study for?
Adults aged 18-85 with moderate to severe runny nose and nasal congestion due to chronic rhinitis, lasting at least 6 months, who are seeking treatment and willing to undergo an office procedure. Excludes those on certain blood thinners or aspirin, with altered nasal anatomy, active infections, poor wound healing risk factors, previous chronic rhinitis surgery or procedures.Check my eligibility
What is being tested?
The effectiveness of the RhinAer ARC Stylus is being evaluated for treating symptoms of chronic rhinitis in adults. This post-market study aims to confirm how well it works following its initial approval.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include discomfort from the procedure itself and typical surgical risks such as infection or bleeding.

RELIEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate to severe runny nose symptoms.
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I am between 18 and 85 years old.
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I experience mild to severe nasal congestion.
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I have had chronic rhinitis for over 6 months and am open to an office procedure.
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I have moderate to severe runny nose symptoms.
Select...
I have moderate to severe runny nose symptoms.
Select...
I am between 18 and 85 years old.

RELIEF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months post study procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months post study procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)
Secondary outcome measures
30% Improvement in Reflective Total Nasal Symptoms Score (rTNSS)
Device Related Adverse Events
Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (RQLQ)

RELIEF Trial Design

1Treatment groups
Experimental Treatment
Group I: RhinAer ARC Stylus TreatmentExperimental Treatment1 Intervention
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 both nostrils treated in the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve.

Find a Location

Who is running the clinical trial?

Aerin MedicalLead Sponsor
11 Previous Clinical Trials
782 Total Patients Enrolled
3 Trials studying Chronic Rhinitis
211 Patients Enrolled for Chronic Rhinitis

Media Library

RhinAer ARC Stylus (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04614324 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must individuals fulfill to enroll in this medical trial?

"Patients with rhinitis between 18 and 85 years old are eligible to participate in this clinical trial, which is aiming to recruit 140 individuals."

Answered by AI

Does this experimental research accept seniors as participants?

"According to the requirements for this research project, individuals must be between 18 and 85 years of age in order to be considered eligible."

Answered by AI

Are researchers currently enrolling participants in this experiment?

"At the current moment, this clinical trial is not accepting applicants. Although first posted on October 5th 2020 and last edited on September 22nd 2022, there are presently 62 other trials that require participants to join them."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
California
How old are they?
65+
What site did they apply to?
Sacramento ENT
Other
Fort Worth ENT
University of Californa, Los Angeles
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Do you treat chronic non allergy rhinitis?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I've been on multiple allergy medicines (1st & 2nd generation) &multiple nose sprays for decades with little relief, as well as Shorts and currently on drops and several medicines.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Californa, Los Angeles: < 24 hours
Average response time
  • < 1 Day
~32 spots leftby Mar 2025