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Posterior Nasal Nerve (PNN) Rhinitis Study

Primary Purpose

Chronic Rhinitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

InSeca Stylus

About this trial

This is an interventional treatment trial for Chronic Rhinitis

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Colorado ENT and Allergy
Advanced ENT and Allergy
Piedmont ENT Associates
Fort Worth ENT
ENT and Allergy Associates of Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

InSeca Stylus Treatment Group

Arm 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)

Outcomes

Primary Outcome Measures

Change in Reflective Total Nasal Symptom Score (rTNSS)

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

Percentage of Participants With Treatment Related Adverse Events (Safety)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03727347

First Posted

October 24, 2018

Last Updated

June 15, 2021

Sponsor

Aerin Medical

1. Study Identification

Unique Protocol Identification Number

NCT03727347

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 16, 2018 (Actual)

Primary Completion Date

February 1, 2020 (Actual)

Study Completion Date

September 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aerin Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All enrolled subjects will be treated with the InSeca Stylus

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

InSeca Stylus Treatment Group

Arm Type

Experimental

Arm 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)

Intervention Type

Device

Intervention Name(s)

InSeca Stylus

Intervention Description

Low power radiofrequency energy delivery to the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus).

Primary Outcome Measure Information:

Title

Change in Reflective Total Nasal Symptom Score (rTNSS)

Description

Time Frame

Comparison of scores at Baseline and 12 weeks post procedure

Title

Percentage of Participants With Treatment Related Adverse Events (Safety)

Description

Time Frame

At or following the study procedure, and up to the final study visit at 1 year.

Other Pre-specified Outcome Measures:

Title

rTNSS Responder Rate

Description

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 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. Subjects who showed at least a 1 point improvement (decrease) in the reflective Total Nasal Symptom Score (rTNSS) were categorized as responders. An overall responder rate of at least 55% was expected.

Time Frame

Comparison of scores at Baseline and 12 weeks post procedure

Title

Change in rTNSS Over Time

Description

Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients report their symptoms reflected or felt over the last 12 hours. Total scores range from 0 to 12. A higher score indicates increased symptom severity. The mean change in the rTNSS total score from Baseline to each follow up visit: 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure will be recorded.

Time Frame

Baseline to each Follow Up Visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure.

Title

Change in rTNSS Individual Nasal Symptom Component Scores Over Time

Description

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. Scores from each of the four components of the questionnaire (rhinorrhea, nasal congestion, nasal itching, and sneezing) will be evaluated at each follow up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure. Individual component scores can range from 0 to 3, with a higher score indicating increased symptom severity.

Time Frame

Baseline to each Follow Up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure

Title

Response on Aerin Quality-of-Life (QOL) Assessment Items

Description

This Quality-of-Life (QOL) instrument is a 9-item patient self-reported questionnaire developed by Aerin Medical to gain understanding of the impact of chronic rhinitis on daily activities, feelings, symptoms and medication use. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. Section 1 asks "Please indicate how often you experience the following" for 6 items. For items 1, 3, 4 and 5, those who answered "never/rarely" were considered to have a positive (favorable) response. For questions 2 and 6, those who answered "frequently/very frequently" were considered to have a positive (favorable) response. Section 2 requests "Please indicate how often you use each of the following products to help you with your chronic rhinitis". For 3 items in this section, those who answered "never/rarely" were considered to have a positive (favorable) response.

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

V. Vasu Kakarlapudi, MD

Organizational Affiliation

Advanced ENT and Allergy, New Albany, IN

Official's Role

Principal Investigator

Facility Information:

Facility Name

Colorado ENT and Allergy

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

Advanced ENT and Allergy

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

Piedmont ENT Associates

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Fort Worth ENT

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76109

Country

United States

Facility Name

ENT and Allergy Associates of Texas

City

McKinney

State/Province

Texas

ZIP/Postal Code

75070

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16719251

Citation

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Results Reference

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PubMed Identifier

18662584

Citation

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Results Reference

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Citation

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PubMed Identifier

6350406

Citation

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Results Reference

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PubMed Identifier

10837577

Citation

Dahl R, Mygind N. Anatomy, physiology and function of the nasal cavities in health and disease. Adv Drug Deliv Rev. 1998 Jan 5;29(1-2):3-12. doi: 10.1016/s0169-409x(97)00058-6.

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PubMed Identifier

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Citation

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PubMed Identifier

22473729

Citation

Schroer B, Pien LC. Nonallergic rhinitis: common problem, chronic symptoms. Cleve Clin J Med. 2012 Apr;79(4):285-93. doi: 10.3949/ccjm.79a11099.

Results Reference

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PubMed Identifier

21364230

Citation

Greiner AN, Meltzer EO. Overview of the treatment of allergic rhinitis and nonallergic rhinopathy. Proc Am Thorac Soc. 2011 Mar;8(1):121-31. doi: 10.1513/pats.201004-033RN.

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PubMed Identifier

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Citation

Halderman A, Sindwani R. Surgical management of vasomotor rhinitis: a systematic review. Am J Rhinol Allergy. 2015 Mar-Apr;29(2):128-34. doi: 10.2500/ajra.2015.29.4141.

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PubMed Identifier

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Citation

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Posterior Nasal Nerve (PNN) Rhinitis Study

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