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

Chronic Rhinitis Clinical Trial

— FROST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181594
• Other study ID #: CT-0003
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: April 6, 2020

Study information

• Verified date: February 2021
• Source: Arrinex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 6, 2020
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

Device:
• ClariFix Device
Cryoablation in the nasal passageway using the ClariFix Device

Locations

Country	Name	City	State
United States	Bethlehem Ear, Nose, and Throat	Bethlehem	Pennsylvania
United States	Ear, Nose, and Throat Associates of South Florida	Boca Raton	Florida
United States	California Sleep Institute	East Palo Alto	California
United States	EVMS Otolaryngology	Norfolk	Virginia
United States	Sacramento Ear, Nose, and Throat	Sacramento	California
United States	San Francisco Otolaryngology Medical Group	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Arrinex, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 Feb 22. doi: 10.1002/lary.29453. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Symptom Severity	Median change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 point or more is considered the minimum clinically important difference.	1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure
Primary	Change From Baseline in Symptom Severity	Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference.	90 days post treatment
Primary	Device- and/or Procedure-related Serious Adverse Events	Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events	90 days post treatment
Secondary	Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	The RQLQ is a validated quality of life questionnaire that evaluates functional problems associated with rhinitis. The questionnaire assess 7 domains: activities, sleep, nose symptoms, eye symptoms, non nose/eye symptoms, practical problems, and emotional function. Each question is scores on a 7-point scale (0=not impaired at all, 6=severely impaired). A domain and total scores are based on the mean of all answered items in that domain resulting in domain or total scores ranging from 0 to 6. An average change on 0.5 or more is considered a minimal clinically important difference.	90 days post treatment