Multi-Treatment PNN Modulation for Chronic Rhinitis



Status:Recruiting
Conditions:Allergy, Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:1/3/2019
Start Date:December 1, 2018
End Date:July 2019

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Feasibility Study of Multi-Treatment Posterior Nasal Nerve Modulation for Treatment of Chronic Rhinitis

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


Inclusion Criteria:

- Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion
symptoms for >3 months.

- Documented allergy test within the last 10 years that defines whether or not subject
has allergies to perennial and seasonal allergens, or is willing to have one performed
prior to study exit.

- Able to provide informed consent and willing to complete study activities and visits
per protocol.

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 posterior
nose.

- 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 adequate
study participation or pose increased risk.
We found this trial at
3
sites
San Francisco, California 94108
Principal Investigator: Jacob Johnson
Phone: 415-362-5443
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Bethlehem, Pennsylvania 18017
Principal Investigator: David Yen, MD
Phone: 610-866-5555
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Fredericksburg, Texas 78624
Principal Investigator: Tracy Byerly, MD
Phone: 830-997-4000
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Fredericksburg, TX
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