Clinical trial NCT03181594: Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
Official title: Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinitis
Keywords: Cryotherapy
Cryoablation
Lead sponsor: Arrinex, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Symptom Severity
timeFrame: 90 days post treatment
measure: Device- and/or Procedure-related Serious Adverse Events
timeFrame: 90 days post treatment
Secondary outcomes:
measure: Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: 90 days post treatment
Other outcomes:
measure: Change From Baseline in Symptom Severity
timeFrame: 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure
Locations:
city: East Palo Alto
country: United States
facility: California Sleep Institute
state: California
city: Sacramento
country: United States
facility: Sacramento Ear, Nose, and Throat
state: California
city: San Francisco
country: United States
facility: San Francisco Otolaryngology Medical Group
state: California
city: Boca Raton
country: United States
facility: Ear, Nose, and Throat Associates of South Florida
state: Florida
city: Bethlehem
country: United States
facility: Bethlehem Ear, Nose, and Throat
state: Pennsylvania
city: Norfolk
country: United States
facility: EVMS Otolaryngology
state: Virginia
Study officials:
References:
citation: Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. 2020 Aug;130(8):1877-1884. doi: 10.1002/lary.28301. Epub 2019 Sep 30.
citation: Ow RA, O'Malley EM, Han JK, Lam KK, Yen DM. Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study. Laryngoscope. 2021 Sep;131(9):1952-1957. doi: 10.1002/lary.29453. Epub 2021 Feb 22.