Summary

Eligibility
for people ages 18-85 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.

Official Title

A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis

Details

Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® ARC Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® ARC Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis.

Keywords

Chronic Rhinitis Rhinitis RhinAer ARC Stylus

Eligibility

You can join if…

Open to people ages 18-85

  1. Age 18 to 85 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 ≥ 6.

You CAN'T join if...

  1. Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
  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. History of significant dry eye.
  5. History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation.
  6. Have rhinitis symptoms only on a seasonal basis due to allergies.
  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. . Has any condition that predisposes to excessive bleeding.
  11. . Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.
  12. . Has previous procedure or surgery for chronic rhinitis.
  13. . 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.

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94115 United States
  • Sacramento ENT not yet accepting patients
    Roseville California 95661 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aerin Medical
ID
NCT04614324
Study Type
Interventional
Last Updated