RECRUITING

A Study of RhinAer Stylus for Treating Chronic Rhinitis

Conditions

Chronic Rhinitis ENT Allergic rhinitis Non-allergic rhinitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.

Official Title

Effect of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve on Inflammatory Biomarkers in Patients With Allergic and Nonallergic Chronic Rhinitis

Quick Facts

Study Start:2024-10-03

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06599736

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 22 to 85 years (inclusively). 2. Willing and able to provide informed consent. 3. Willing and able to comply with the patient-specific requirements outlined in the study protocol. 4. Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (allergic or nonallergic) of at least 12 months duration 5. Willing to undergo the RhinAer procedure 6. Has a baseline rTNSS symptom score of ≥6 at time of screening 7. If on anticoagulation therapy, anticoagulant medications can be withheld during the perioperative period (at least 3-day window pre- and post-procedure). 8. Has been diagnosed with either allergic or non-allergic chronic rhinitis and meet the following criteria: * a. Allergic rhinitis: diagnosed with perennial (non-seasonal) allergic rhinitis and has demonstrated sensitization to specific allergens through skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the allergic nature of their rhinitis within the past 24 months.	1. Anatomic obstructions in the nasal passage(s) that in the investigator's opinion limits access to the posterior nasal nerve treatment area. 2. Has seasonal rhinitis symptoms. 3. Current or recent use of biologic therapy within past 3 months. 4. History of chronic epistaxis or has had episodes of significant nose bleeds in the past 3 months. 5. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure. 6. Known or suspected to be pregnant or is lactating. 7. Has any condition resulting in a predisposition to excessive bleeding (e.g., hereditary hemorrhagic telangiectasia \[HHT\]). 8. Has diagnosis of rhinitis medicamentosa, an active nasal or sinus infection or has a history of 'dry eye.' 9. Has had previous procedure or surgery for chronic rhinitis (e.g., PNN ablation). 10. Has had a nasal or sinus surgical procedure in the past six (6) months. 11. Currently participating in another clinical research study or has participated in an interventional study within the past 3 months. 12. Has a planned adjunctive procedure at the time of the study procedure or within the 6-month study follow-up period 13. Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.

Inclusion Criteria

Exclusion Criteria

1. Age 22 to 85 years (inclusively).
2. Willing and able to provide informed consent.
3. Willing and able to comply with the patient-specific requirements outlined in the study protocol.
4. Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (allergic or nonallergic) of at least 12 months duration
5. Willing to undergo the RhinAer procedure
6. Has a baseline rTNSS symptom score of ≥6 at time of screening
7. If on anticoagulation therapy, anticoagulant medications can be withheld during the perioperative period (at least 3-day window pre- and post-procedure).
8. Has been diagnosed with either allergic or non-allergic chronic rhinitis and meet the following criteria:
* a. Allergic rhinitis: diagnosed with perennial (non-seasonal) allergic rhinitis and has demonstrated sensitization to specific allergens through skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the allergic nature of their rhinitis within the past 24 months.

1. Anatomic obstructions in the nasal passage(s) that in the investigator's opinion limits access to the posterior nasal nerve treatment area.
2. Has seasonal rhinitis symptoms.
3. Current or recent use of biologic therapy within past 3 months.
4. History of chronic epistaxis or has had episodes of significant nose bleeds in the past 3 months.
5. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure.
6. Known or suspected to be pregnant or is lactating.
7. Has any condition resulting in a predisposition to excessive bleeding (e.g., hereditary hemorrhagic telangiectasia \[HHT\]).
8. Has diagnosis of rhinitis medicamentosa, an active nasal or sinus infection or has a history of 'dry eye.'
9. Has had previous procedure or surgery for chronic rhinitis (e.g., PNN ablation).
10. Has had a nasal or sinus surgical procedure in the past six (6) months.
11. Currently participating in another clinical research study or has participated in an interventional study within the past 3 months.
12. Has a planned adjunctive procedure at the time of the study procedure or within the 6-month study follow-up period
13. Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.

Contacts and Locations

Study Contact

Tien Dang

CONTACT

669-256-6596

tdang@aerinmedical.com

Noor Hason

CONTACT

615-680-5168

nhason@aerinmedical.com

Study Locations (Sites)

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923

United States

Collaborators and Investigators

Sponsor: Aerin Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-03

Study Completion Date2025-08

Study Record Updates

Study Start Date2024-10-03

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

ENT
Chronic rhinitis
Allergic rhinitis
Non-allergic rhinitis

Additional Relevant MeSH Terms

Chronic Rhinitis