Clinical trial NCT03727347: Posterior Nasal Nerve (PNN) Rhinitis Study
Official title: Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinitis
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled subjects will be treated with the InSeca Stylus
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: Comparison of scores at Baseline and 12 weeks post procedure
measure: Percentage of Participants With Treatment Related Adverse Events (Safety)
timeFrame: At or following the study procedure, and up to the final study visit at 1 year.
Secondary outcomes:
Other outcomes:
measure: rTNSS Responder Rate
timeFrame: Comparison of scores at Baseline and 12 weeks post procedure
measure: Change in rTNSS Over Time
timeFrame: Baseline to each Follow Up Visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure.
measure: Change in rTNSS Individual Nasal Symptom Component Scores Over Time
timeFrame: Baseline to each Follow Up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure
measure: Response on Aerin Quality-of-Life (QOL) Assessment Items
timeFrame: The QOL was to be completed by the subject at baseline prior to the treatment procedure, and at the 12 week, 26 week and 52 week visits post procedure.
Locations:
city: Colorado Springs
country: United States
facility: Colorado ENT and Allergy
state: Colorado
city: New Albany
country: United States
facility: Advanced ENT and Allergy
state: Indiana
city: Winston-Salem
country: United States
facility: Piedmont ENT Associates
state: North Carolina
city: Fort Worth
country: United States
facility: Fort Worth ENT
state: Texas
city: McKinney
country: United States
facility: ENT and Allergy Associates of Texas
state: Texas
Study officials:
affiliation: Advanced ENT and Allergy, New Albany, IN
name: V. Vasu Kakarlapudi, MD
role: PRINCIPAL_INVESTIGATOR
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