Multi-Treatment PNN Modulation for Chronic Rhinitis
Completed · Not applicable
Conditions studied: Chronic Rhinitis
In brief
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
Key facts
- Study ID
- NCT03791489
- Run by
- Arrinex, Inc.
- People needed
- 30
- Starts
- 2018-12-01
- Expected to finish
- 2019-07-18
- Last updated by the study team
- 2020-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- San Francisco Otolaryngology Medical Group — San Francisco, California, United States
- Bethlehem ENT — Bethlehem, Pennsylvania, United States
- Tracy Byerly, MD — Fredericksburg, Texas, United States
Full record on ClinicalTrials.gov
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