Posterior Nasal Nerve (PNN) Rhinitis Study

Not Applicable

Completed

• Conditions: Chronic Rhinitis
• Interventions: Device: InSeca Stylus

• Registration Number: NCT03727347
• Lead Sponsor: Aerin Medical

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-10-16
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-01
• Primary Completion: 2020-02-01
• Status Verified: 2020-09
• Study Completion: 2020-09-17
• Results First Submitted: 2021-05-21
• Results First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-15
• Results First Posted: 2021-06-16
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
InSeca Stylus Treatment Group	InSeca Stylus	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)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Related Adverse Events (Safety)	At or following the study procedure, and up to the final study visit at 1 year.	Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure. Subjects were asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. Each event was documented and identified as to its relationship and level of relatedness to the study device and/or study procedure.; This measure includes any subject who experienced at least one event considered definitely, probably, or possibly related to the device or procedure.
Change in Reflective Total Nasal Symptom Score (rTNSS)	Comparison of scores at Baseline and 12 weeks post procedure	Mean change in Reflective Total Nasal Symptoms Score (rTNSS) from baseline to 12 weeks post-study procedure. Improvement (12 week score - baseline score) is signified by a negative value.; The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. This study will measure the mean change in the rTNSS total score from Baseline to 12 week follow up visit

Trial Locations

Locations (5)

Fort Worth ENT; 🇺🇸 Fort Worth, Texas, United States

ENT and Allergy Associates of Texas; 🇺🇸 McKinney, Texas, United States

Piedmont ENT Associates; 🇺🇸 Winston-Salem, North Carolina, United States

Colorado ENT and Allergy; 🇺🇸 Colorado Springs, Colorado, United States

Advanced ENT and Allergy; 🇺🇸 New Albany, Indiana, United States