N/A
N=50
Posterior Nasal Nerve (PNN) Rhinitis Study
Chronic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT03727347 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Jun 2021
Primary outcome: Primary: Change in Reflective Total Nasal Symptom Score (rTNSS) — -5.1 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- InSeca Stylus (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Aerin Medical
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Reflective Total Nasal Symptom Score (rTNSS) |
-5.1 | <0.0001 sig |
| PRIMARY Percentage of Participants With Treatment Related Adverse Events (Safety) |
8 | — |
Summary
Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis
Eligibility Criteria
Inclusion Criteria
- Age 22 to 75 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 score of greater than or equal to 6
- Dissatisfaction with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief, as judged by the subject
Exclusion Criteria
- Anatomic obstructions that in the investigator's opinion limit access to the posterior nose
- Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury
- Active nasal or sinus infection
- Moderate to severe ocular allergic symptoms (such as eye tearing [epiphora], itching [pruritus], or redness [erythema])
- History of significant dry eye
- History of any of the following: nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation
- 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
- 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 (NCT03727347). 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.