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ClariFix Cryoablation Clinical Study

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ClinicalTrials.gov Identifier: NCT02820597
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Arrinex, Inc.

Brief Summary:
This pilot study is a single arm study designed to evaluate the feasibility of cryoablation in the nasal passageway using the ClariFix Device, to reduce the symptoms of chronic rhinitis.

Condition or disease Intervention/treatment Phase
Rhinitis Device: ClariFix Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Cryotherapy in the Nasal Passageway Using the ClariFix Device
Actual Study Start Date : June 15, 2015
Actual Primary Completion Date : February 5, 2016
Actual Study Completion Date : July 20, 2016

Arm Intervention/treatment
Experimental: Intervention
Treatment with the ClariFix Device
Device: ClariFix Device



Primary Outcome Measures :
  1. Frequency of device- and procedure-related adverse events [ Time Frame: 3 months ]
    Safety will be evaluated based on the frequency of device- and procedure-related adverse events reported over the study follow up period

  2. Change in symptom severity [ Time Frame: 3 months ]
    Change in subject reported symptom severity based on rTNSS (Reflective Total Nasal Symptom Score) at baseline and at 7, 30, and 90 days post-treatment. The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores will be based on the subject's evaluation of symptom severity over the preceding 12 hours.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Arrinex, Inc.
ClinicalTrials.gov Identifier: NCT02820597     History of Changes
Other Study ID Numbers: A2014-02
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases