Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-02

Study Completion Date

2020-04-06

Brief Summary

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A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.

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Detailed Description

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Conditions

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Chronic Rhinitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with the ClariFix Device

Bilateral ablation of nasal tissue for treatment of chronic rhinitis

Group Type EXPERIMENTAL

ClariFix Device

Intervention Type DEVICE

Cryoablation in the nasal passageway using the ClariFix Device

Interventions

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ClariFix Device

Cryoablation in the nasal passageway using the ClariFix Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject is \>21 years of age
2. Subject has moderate to severe symptoms of rhinorrhea (individual symptom rating of 2 or 3), mild to severe symptoms of congestion (individual symptom rating of 1, 2 or 3) and a minimum TNSS score of 4 (out of 12) at the time of the treatment visit, which have been present for \> 6 months.
3. Subject has had 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.
4. Subject has been dissatisfied with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief by the subject's assessment.
5. Subject has signed IRB-approved informed consent form

Exclusion Criteria

1. Subject has clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to septal deviation or perforation, nasal polyps, sinonasal tumor.
2. Subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
3. Subject has active nasal or sinus infection.
4. Subject has moderate to severe ocular symptoms.
5. Subject has a history of nosebleeds in the past 3 months.
6. Subject has a history of rhinitis medicamentosa.
7. Subject has had prior head or neck irradiation
8. Subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin).
9. Subject is pregnant.
10. Subject is participating in another clinical research study.
11. Subject has an allergy or intolerance to anesthetic agent.
12. Subject has cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
13. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No