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RhinAer ARC Stylus for Chronic Rhinitis (RELIEF Trial)
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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 belowSelect...
I have moderate to severe runny nose symptoms.
Select...
I am between 18 and 85 years old.
Select...
I experience mild to severe nasal congestion.
Select...
I have had chronic rhinitis for over 6 months and am open to an office procedure.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 months post study procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months post study procedure
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing and able to comply with the requirements of the study.I have moderate to severe runny nose symptoms.I experience mild to severe nasal congestion.I experience mild to severe nasal congestion.I am between 18 and 85 years old.I have had chronic rhinitis for over 6 months and am open to an office procedure.I experience mild to severe nasal congestion.I am on blood thinners like warfarin or aspirin that I can't stop before a procedure.I have had chronic nosebleeds, significant nose bleeds in the last 3 months, medication-induced nasal issues, or radiation therapy to the head or neck.I have had chronic rhinitis for over 6 months and am open to an office procedure.I have a condition that causes me to bleed easily.I only have nasal symptoms during certain seasons due to allergies.I have moderate to severe runny nose symptoms.I have had chronic rhinitis for over 6 months and am open to an office procedure.I have moderate to severe runny nose symptoms.I have a history of severe dry eye.My nose's structure is changed due to past surgery or injury.I currently have a nasal or sinus infection.I don't have health issues that could affect my healing or participation in the study.Your nasal symptoms score is 6 or higher.I have had surgery for long-term nose inflammation.Your nasal symptoms score is 6 or higher.I am between 18 and 85 years old.I have a blockage that makes it hard to reach the back of my nose.
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:
- University of Californa, Los Angeles: < 24 hours
Average response time
- < 1 Day
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