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ClariFix Rhinitis RCT (CR RCT)

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ClinicalTrials.gov Identifier: NCT04154605
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
North American Science Associates Inc.
Information provided by (Responsible Party):
Entellus Medical, Inc.

Brief Summary:
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.

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

Detailed Description:
A prospective, multicenter, randomized, sham-controlled, single-blind (participants) study to demonstrate the superiority of treatment with the ClariFix cryotherapy device for reducing symptoms when compared with a sham treatment in patients with chronic rhinitis. The ClariFix device is a Class II FDA-cleared medical device that is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be randomized 1:1 to ClariFix or a sham procedure. After the 90-day visit, control participants may crossover to active ClariFix treatment, if they continue to meet enrollment criteria.
Masking: Single (Participant)
Masking Description: All participants will be blinded to treatment assignment from procedure through their 90-day visit.
Primary Purpose: Treatment
Official Title: ClariFix Rhinitis Randomized Controlled Trial
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Active Comparator: ClariFix
Cryotherapy of the nasal passages with the ClariFix device.
Device: ClariFix cryotherapy
Bilateral freeze ablation of nasal tissue using the ClariFix device.

Sham Comparator: Sham
Sham cryotherapy of the nasal passages with the ClariFix device
Device: Sham ClariFix cryotherapy
Bilateral sham ablation procedure using the ClariFix device.
Other Name: Sham




Primary Outcome Measures :
  1. rTNSS responder rate [ Time Frame: 90-days post treatment ]

    Responders are defined as participants with a 30% or greater reduction in reflective Total Nasal Symptom Score (rTNSS) relative to baseline. The active treatment will be compared with the sham treatment.

    The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12.



Secondary Outcome Measures :
  1. Change in rTNSS [ Time Frame: 90 days post treatment ]

    Mean change from baseline in the rTNSS. The active treatment will be compared with the sham treatment.

    The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12.


  2. Change in RQLQ(S) [ Time Frame: 90 days post treatment ]

    Mean change from baseline in the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) score. The active treatment will be compared with the sham treatment.

    The RQLQ(S) is a validated PRO that measures functional impairments due to allergic or non-allergic rhinoconjunctivitis. The assessment consists of 28 questions related to nose symptoms, eye symptoms, non-eye/nose symptoms, sleep problems, practical problems, activity limitations, and emotional function. Each item is scored from 0 (no impairment) to 6 (severely impaired). An overall score is calculated from the mean of the 28 item responses. Domain scores are the mean of the item scores within that domain.


  3. Change in EQ-5D-5L [ Time Frame: 90 days post treatment ]

    Mean change from baseline in the 5-level EuroQol 5-dimension survey (EQ-5D-5L) scores. The active treatment will be compared with the sham treatment.

    The EQ-5D-5L is a validated, standardized questionnaire used to evaluate general health-related quality of life. The questionnaire consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analog scale (VAS) to indicate overall health on a scale of 0 to 100. Each health dimension has 5 possible responses: no problems, slight problems, moderate problems, severe problems, or extreme problems.


  4. Patient satisfaction questionnaire [ Time Frame: 90 days post treatment ]

    Percent of participants indicating satisfaction with the procedure outcome. The active treatment will be compared with the sham treatment.

    The satisfaction questionnaire consists of 3 questions that the participant answers at each follow-up visit. The questions indicate whether the participant is satisfied with the procedure outcome, whether the participant would undergo the procedure again for similar results, and whether the participant would recommend the procedure to family or friends with a similar condition. For each item the participant indicates agreement/disagreement with each statement.


  5. Serious device- and/or procedure-related adverse events [ Time Frame: 90 days post procedure ]
    The number of participants with one or more serious adverse events that are possibly, probably, or definitely related to the ClariFix device and/or procedure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Be ≥21 years of age.
  2. Has been diagnosed with chronic nonallergic or allergic rhinitis.
  3. Have moderate to severe symptoms of rhinorrhea (individual reflective Total Nasal Symptoms Score [rTNSS] symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total rTNSS of 4 (out of 12) at baseline.
  4. Have an allergy test (by skin prick or intradermal testing or by validated in vitro tests for specific Immunoglobin E [IgE]) on file within 12 months of the baseline visit.
  5. Be an appropriate candidate for bilateral ClariFix treatment performed under local anesthesia.
  6. Be willing and able to comply with all study elements, as indicated by their written informed consent.
  7. Be willing and able to comply with all study elements and provide written consent.

Exclusion Criteria:

  1. Have clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
  2. Have had previous sinus or nasal surgery within 6 months of study enrollment.
  3. Have previously undergone cryotherapy or other surgical interventions for rhinitis.
  4. Have an active nasal or sinus infection.
  5. Have rhinitis symptoms that are primarily due to seasonal allergies.
  6. Have plans to (or otherwise anticipates the need to) undergo an ENT (ear, nose, throat) procedure concurrently or within 3 months after the study procedure.
  7. Is on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure (81 mg aspirin and herbal supplements are acceptable).
  8. Be unable to discontinue ipratropium bromide (IB) at least 14 days before baseline and through the 90-day follow-up visit.
  9. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
  10. Have a history of rhinitis medicamentosa.
  11. Have had previous head and/or neck irradiation.
  12. Have an allergy or intolerance to local anesthetic agents.
  13. Have cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or open and/or infected wounds at or near the target tissue.
  14. Have a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data.
  15. Be participating in another clinical research study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154605


Contacts
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Contact: Ellen O'Malley 763-464-1598 ellen.omalley@stryker.com
Contact: Robyn Schacherer 763-463-7054 robyn.schacherer@stryker.com

Locations
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United States, Florida
ENT Associates of South Florida Recruiting
Coral Springs, Florida, United States, 33065
Contact: Curtis Johnson, DO         
Contact: Patricia Fonseca       pfonseca@entsf.com   
Sponsors and Collaborators
Entellus Medical, Inc.
North American Science Associates Inc.
Investigators
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Principal Investigator: Anthony DelSignore, MD Ichan School of Medicine, Mount Sinai, New York, NY
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Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT04154605    
Other Study ID Numbers: 4666-001
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Entellus Medical, Inc.:
Cryotherapy
Cryoablation
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases