Posterior Nasal Nerve (PNN) Rhinitis Study

Aerin Medical

Status: Completed

Conditions: Chronic Rhinitis

Treatments: Device: InSeca Stylus

Study type: Interventional

Funder types: Industry

Identifiers

NCT03727347

TP668

Details and patient eligibility

About

Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis

Full description

This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (InSeca Stylus) when used to deliver radiofrequency (RF) energy to the posterior nasal nerve area to improve symptoms in those diagnosed with chronic rhinitis.

Enrollment: 50 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 22 to 75 years (inclusively)
2. Willing and able to provide informed consent
3. Willing and able to comply with the subject-specific requirements outlined in the study protocol
4. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure
5. Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea)
6. Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion)
7. rTNSS score of greater than or equal to 6
8. 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

1. Anatomic obstructions that in the investigator's opinion limit access to the posterior nose
2. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury
3. Active nasal or sinus infection
4. Moderate to severe ocular allergic symptoms (such as eye tearing [epiphora], itching [pruritus], or redness [erythema])
5. History of significant dry eye
6. History of any of the following: nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation
7. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session
8. Known or suspected to be pregnant, or is lactating
9. Participating in another clinical research study
10. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

InSeca Stylus Treatment Group

Experimental group

Description:

Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)

Treatment:

Device: InSeca Stylus