Posterior Nasal Nerve (PNN) Rhinitis Study



Status:Recruiting
Conditions:Allergy, Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:22 - 75
Updated:11/3/2018
Start Date:October 16, 2018
End Date:February 1, 2020
Contact:Scott Wolf, MD
Email:scott@aerinmedical.com
Phone:650-597-0111

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Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis

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

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.

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. Documented allergy test (for seasonal or perennial allergens) within the last 10 years
OR willing to undergo allergy testing prior to 12-week follow-up visit (blood panel
testing results are acceptable)

9. 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
We found this trial at
4
sites
Winston-Salem, North Carolina 27103
Principal Investigator: Ronald B. Shealy, MD
Phone: 336-768-3361
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Colorado Springs, Colorado 80909
Principal Investigator: Bryan Davis, MD
Phone: 719-867-7810
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Colorado Springs, CO
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McKinney, Texas 75070
Principal Investigator: Dale Ehmer, MD
Phone: 972-731-7654
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McKinney, TX
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New Albany, Indiana 47150
Principal Investigator: V. Vasu Kakarlapudi, MD
Phone: 502-995-0159
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New Albany, IN
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