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ClariFix Rhinitis RCT (CR RCT)

Primary Purpose

Chronic Rhinitis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ClariFix cryotherapy
Sham ClariFix cryotherapy
Sponsored by
Entellus Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinitis focused on measuring Cryotherapy, Cryoablation

Eligibility Criteria

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

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.

Sites / Locations

  • ENT Associates of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ClariFix

Sham

Arm Description

Cryotherapy of the nasal passages with the ClariFix device.

Sham cryotherapy of the nasal passages with the ClariFix device

Outcomes

Primary Outcome Measures

rTNSS Responder Rate
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

rTNSS Responder Rate
Mean change from baseline in the rTNSS. 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.
Change in Total RQLQ(S)
Mean change from baseline in the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) score. 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.
Patient Satisfaction Questionnaire
Percent of participants indicating satisfaction with the procedure outcome. 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.
Serious Device- and/or Procedure-related Adverse Events
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.

Full Information

First Posted
October 31, 2019
Last Updated
September 20, 2021
Sponsor
Entellus Medical, Inc.
Collaborators
North American Science Associates Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04154605
Brief Title
ClariFix Rhinitis RCT
Acronym
CR RCT
Official Title
ClariFix Rhinitis Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entellus Medical, Inc.
Collaborators
North American Science Associates 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
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinitis
Keywords
Cryotherapy, Cryoablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
All participants will be blinded to treatment assignment from procedure through their 90-day visit.
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ClariFix
Arm Type
Active Comparator
Arm Description
Cryotherapy of the nasal passages with the ClariFix device.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham cryotherapy of the nasal passages with the ClariFix device
Intervention Type
Device
Intervention Name(s)
ClariFix cryotherapy
Intervention Description
Bilateral freeze ablation of nasal tissue using the ClariFix device.
Intervention Type
Device
Intervention Name(s)
Sham ClariFix cryotherapy
Other Intervention Name(s)
Sham
Intervention Description
Bilateral sham ablation procedure using the ClariFix device.
Primary Outcome Measure Information:
Title
rTNSS Responder Rate
Description
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.
Time Frame
90-days post treatment
Secondary Outcome Measure Information:
Title
rTNSS Responder Rate
Description
Mean change from baseline in the rTNSS. 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.
Time Frame
Through 12 months post treatment
Title
Change in Total RQLQ(S)
Description
Mean change from baseline in the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) score. 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.
Time Frame
Through 12 months post treatment
Title
Patient Satisfaction Questionnaire
Description
Percent of participants indicating satisfaction with the procedure outcome. 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.
Time Frame
Through 12 months post treatment
Title
Serious Device- and/or Procedure-related Adverse Events
Description
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.
Time Frame
Through 12 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be ≥21 years of age. Has been diagnosed with chronic nonallergic or allergic rhinitis. 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. 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. Be an appropriate candidate for bilateral ClariFix treatment performed under local anesthesia. Be willing and able to comply with all study elements, as indicated by their written informed consent. Be willing and able to comply with all study elements and provide written consent. Exclusion Criteria: 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. Have had previous sinus or nasal surgery within 6 months of study enrollment. Have previously undergone cryotherapy or other surgical interventions for rhinitis. Have an active nasal or sinus infection. Have rhinitis symptoms that are primarily due to seasonal allergies. 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. 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). Be unable to discontinue ipratropium bromide (IB) at least 14 days before baseline and through the 90-day follow-up visit. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months. Have a history of rhinitis medicamentosa. Have had previous head and/or neck irradiation. Have an allergy or intolerance to local anesthetic agents. Have cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or open and/or infected wounds at or near the target tissue. Have a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data. Be participating in another clinical research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony DelSignore, MD
Organizational Affiliation
Ichan School of Medicine, Mount Sinai, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
ENT Associates of South Florida
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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ClariFix Rhinitis RCT

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