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Completed

NCT Number: NCT03727347

Posterior Nasal Nerve (PNN) Rhinitis Study

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

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Key information

Conditions

Chronic Rhinitis

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado ENT and Allergy, Colorado Springs, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InSeca Stylus

Device

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 outcomes

  1. Change in Reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 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

  2. Percentage of Participants With Treatment Related Adverse Events (Safety)

    Time frame: 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.

Other outcomes

  1. rTNSS Responder Rate

    Time frame: Comparison of scores at Baseline and 12 weeks post procedure

    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.

  2. Change in rTNSS Over Time

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

    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.

  3. Change in rTNSS Individual Nasal Symptom Component Scores Over Time

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

    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.

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

    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.

    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.

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2018
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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