N/A
N=116
RhinAer Procedure for Treatment of Chronic Rhinitis Study
Chronic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT04533438 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Reflective Total Nasal Symptom Score (rTNSS) Responder Rate — 52; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RhinAer Stylus (Device); Sham (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aerin Medical
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reflective Total Nasal Symptom Score (rTNSS) Responder Rate |
52; 16 | — |
| SECONDARY Reflective Total Nasal Symptom Score (rTNSS) Mean Change |
-4.8 | — |
| SECONDARY Reflective Total Nasal Symptom Score (rTNSS) Mean Change |
-4.8 | — |
| SECONDARY Percentage of Participants With Treatment Related Events (Safety) |
1; 0; 1; 0; 0; 1 | — |
Summary
The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 85 years (inclusively).
- Willing and able to provide informed consent.
- Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
- Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure.
- Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea).
- Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion).
- rTNSS ≥ 6.
Exclusion Criteria
- Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
- Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
- Active nasal or sinus infection.
- History of significant dry eye.
- History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation.
- Have rhinitis symptoms only on a seasonal basis due to allergies.
- Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
- Known or suspected to be pregnant or is lactating.
- Participating in another clinical research study.
- Has any condition that predisposes to excessive bleeding.
- Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.
- Has previous procedure or surgery for chronic rhinitis.
- Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.
Data sourced from ClinicalTrials.gov (NCT04533438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.