Clinical trial NCT02820597: ClariFix Cryoablation Clinical Study
Official title: Clinical Evaluation of Cryotherapy in the Nasal Passageway Using the ClariFix Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis
Lead sponsor: Arrinex, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 27
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: This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.

Detailed description: This is a small, prospective, multicenter, single-arm, self-controlled interventional feasibility study to evaluation cryoablation in the nasal passage as a treatment for chronic rhinitis. The ClariFix device is FDA-cleared device with the intended use for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

Eligibility criteria: Inclusion Criteria:

1. Subject is \>21 years of age
2. Subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion for \>3 months (rTNSS rating of 2 or 3)
3. Subject has signed IRB-approved informed consent form

Exclusion Criteria:

1. Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
2. Subject has a septal perforation
3. Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
4. Subject has had prior head or neck irradiation
5. Subject has active or chronic nasal or sinus infection
6. Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks
7. Subject has a history of dry nose symptoms
8. Subject is pregnant or lactating
9. Subject is participating in another clinical research study
10. Subject has an allergy or intolerance to anesthetic agent
11. Subject is an active smoker or has been a smoker within the last 6 months
12. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk

Primary outcomes:
measure: Device- and/or Procedure-related Serious Adverse Events
timeFrame: Baseline through 365 days post treatment
measure: Change in Rhinitis Symptom Severity (rTNSS)
timeFrame: Baseline through 365 days post treatment
measure: Change in Rhinitis Symptoms (VAS)
timeFrame: Baseline through 365 days post treatment
Secondary outcomes:
measure: Ease of Use
timeFrame: Immediately post treatment
measure: Device- and/or Procedure-related Adverse Events
timeFrame: Baseline through 90 days post treatment
Other outcomes:
Locations:
Study officials:
affiliation: San Francisco Otolaryngology Medical Group
name: Jacob Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hwang PH, Lin B, Weiss R, Atkins J, Johnson J. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. 2017 Oct;7(10):952-956. doi: 10.1002/alr.21991. Epub 2017 Aug 11.