ClariFix Rhinitis RCT (CR RCT)

ClariFix Rhinitis Randomized Controlled Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Rhinitis
• Intervention / Treatment: Device: ClariFix cryotherapy; Device: Sham ClariFix cryotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Springs, Florida, United States, 33065
      • ENT Associates of South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90-days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through 12 months post treatment
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.	Through 12 months post treatment
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.	Through 12 months post treatment
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.	Through 12 months post procedure

Collaborators and Investigators

• Sponsor: Entellus Medical, Inc.
• Collaborators: North American Science Associates Inc.
• Investigators: Principal Investigator: Anthony DelSignore, MD, Ichan School of Medicine, Mount Sinai, New York, NY

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cryoablation; Cryotherapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: 4666-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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