Status:
COMPLETED
Multi-Treatment PNN Modulation for Chronic Rhinitis
Lead Sponsor:
Arrinex, Inc.
Conditions:
Chronic Rhinitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03791489
Start Date
December 1 2018
End Date
July 18 2019
Last Update
July 24 2020
Active Locations (3)
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1
San Francisco Otolaryngology Medical Group
San Francisco, California, United States, 94108
2
Bethlehem ENT
Bethlehem, Pennsylvania, United States, 18017
3
Tracy Byerly, MD
Fredericksburg, Texas, United States, 78624