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



Status:Active, not recruiting
Conditions:Allergy, Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:21 - Any
Updated:1/2/2019
Start Date:March 2, 2017
End Date:April 30, 2019

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Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis

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.


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.
We found this trial at
6
sites
Sacramento, California 95815
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Bethlehem, Pennsylvania 18017
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Boca Raton, FL
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East Palo Alto, California 94303
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East Palo Alto, CA
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600 Gresham Drive
Norfolk, Virginia 23507
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Norfolk, VA
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San Francisco, California 94108
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San Francisco, CA
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