Multi-Treatment PNN Modulation for Chronic Rhinitis

Arrinex

Status: Completed

Conditions: Chronic Rhinitis

Treatments: Device: ClariFix

Study type: Interventional

Funder types: Industry

Identifiers

NCT03791489

CT-0005

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Active Treatment

Experimental group

Description:

Cryotherapy of the posterior nasal nerve using the ClariFix device

Treatment:

Device: ClariFix