Posterior Nasal Nerve (PNN) Rhinitis Study

Last updated: June 15, 2021
Sponsor: Aerin Medical
Overall Status: Completed

Phase

N/A

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT03727347
TP668
  • Ages 22-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 thestudy protocol
  4. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration andwilling 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 aminimum of 4 weeks without adequate symptom relief, as judged by the subject

Exclusion

Exclusion Criteria:

  1. Anatomic obstructions that in the investigator's opinion limit access to the posteriornose
  2. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery orinjury
  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, rhinitismedicamentosa, head or neck irradiation
  7. Known or suspected allergies or contraindications to the anesthetic agents and/orantibiotic 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 thesubject to poor wound healing, increased surgical risk, or poor compliance with therequirements of the study

Study Design

Total Participants: 50
Study Start date:
October 16, 2018
Estimated Completion Date:
September 17, 2020

Study 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.

Connect with a study center

  • Colorado ENT and Allergy

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Advanced ENT and Allergy

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Piedmont ENT Associates

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Fort Worth ENT

    Fort Worth, Texas 76109
    United States

    Site Not Available

  • ENT and Allergy Associates of Texas

    McKinney, Texas 75070
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.