Multi-Treatment PNN Modulation for Chronic Rhinitis

Last updated: July 23, 2020
Sponsor: Arrinex, Inc.
Overall Status: Completed

Phase

N/A

Condition

Common Cold

Allergy

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT03791489
CT-0005
  • Ages > 18
  • All Genders

Study Summary

Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestionsymptoms for >3 months.

  • Documented allergy test within the last 10 years that defines whether or not subjecthas allergies to perennial and seasonal allergens, or is willing to have one performedprior to study exit.

  • Able to provide informed consent and willing to complete study activities and visitsper protocol.

Exclusion

Exclusion Criteria:

  • Clinically significant anatomic obstructions that limit access to the posterior nose.

  • Prior sinus or nasal surgery that significantly alters the anatomy of the posteriornose.

  • Moderate to severe ocular symptoms as determined.

  • History of epistaxis in the past 3 months.

  • History of rhinitis medicamentosa.

  • Prior head or neck irradiation.

  • Active or chronic nasal or sinus infection.

  • Pregnant.

  • Allergy or intolerance to anesthetic agent.

  • Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease,and/or, open and/or infected wounds at or near the target tissue.

  • Currently participating in another clinical research study.

  • Any physical condition that, in the investigator's opinion, would prevent adequatestudy participation or pose increased risk.

Study Design

Total Participants: 30
Study Start date:
December 01, 2018
Estimated Completion Date:
July 18, 2019

Connect with a study center

  • San Francisco Otolaryngology Medical Group

    San Francisco, California 94108
    United States

    Site Not Available

  • Bethlehem ENT

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Tracy Byerly, MD

    Fredericksburg, Texas 78624
    United States

    Site Not Available

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