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ClariFix Cryoablation Clinical Study

Primary Purpose

Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ClariFix device
Sponsored by
Arrinex, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Cryoablation with the ClariFix device

    Outcomes

    Primary Outcome Measures

    Device- and/or Procedure-related Serious Adverse Events
    Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.
    Change in Rhinitis Symptom Severity (rTNSS)
    Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). 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 range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours.
    Change in Rhinitis Symptoms (VAS)
    Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10.

    Secondary Outcome Measures

    Ease of Use
    Physician evaluation of ClariFix ease of use. After each participant's treatment, the physician was asked to rate the ClariFix on ease of use. Options were easy, moderately easy, moderately difficult, or difficult.
    Device- and/or Procedure-related Adverse Events
    All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.

    Full Information

    First Posted
    June 29, 2016
    Last Updated
    October 17, 2019
    Sponsor
    Arrinex, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02820597
    Brief Title
    ClariFix Cryoablation Clinical Study
    Official Title
    Clinical Evaluation of Cryotherapy in the Nasal Passageway Using the ClariFix Device
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 15, 2015 (Actual)
    Primary Completion Date
    February 5, 2016 (Actual)
    Study Completion Date
    July 20, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Arrinex, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Cryoablation with the ClariFix device
    Intervention Type
    Device
    Intervention Name(s)
    ClariFix device
    Primary Outcome Measure Information:
    Title
    Device- and/or Procedure-related Serious Adverse Events
    Description
    Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.
    Time Frame
    Baseline through 365 days post treatment
    Title
    Change in Rhinitis Symptom Severity (rTNSS)
    Description
    Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). 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 range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours.
    Time Frame
    Baseline through 365 days post treatment
    Title
    Change in Rhinitis Symptoms (VAS)
    Description
    Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10.
    Time Frame
    Baseline through 365 days post treatment
    Secondary Outcome Measure Information:
    Title
    Ease of Use
    Description
    Physician evaluation of ClariFix ease of use. After each participant's treatment, the physician was asked to rate the ClariFix on ease of use. Options were easy, moderately easy, moderately difficult, or difficult.
    Time Frame
    Immediately post treatment
    Title
    Device- and/or Procedure-related Adverse Events
    Description
    All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.
    Time Frame
    Baseline through 90 days post treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is >21 years of age Subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion for >3 months (rTNSS rating of 2 or 3) Subject has signed IRB-approved informed consent form Exclusion Criteria: Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor Subject has a septal perforation Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose Subject has had prior head or neck irradiation Subject has active or chronic nasal or sinus infection Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks Subject has a history of dry nose symptoms Subject is pregnant or lactating Subject is participating in another clinical research study Subject has an allergy or intolerance to anesthetic agent Subject is an active smoker or has been a smoker within the last 6 months Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jacob Johnson, MD
    Organizational Affiliation
    San Francisco Otolaryngology Medical Group
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28799727
    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.
    Results Reference
    result

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    ClariFix Cryoablation Clinical Study

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