Clinical trial NCT04154605: ClariFix Rhinitis RCT
Official title: ClariFix Rhinitis Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinitis
Keywords: Cryotherapy
Cryoablation
Lead sponsor: Stryker Instruments
Sponsor class: INDUSTRY
Collaborators: name: North American Science Associates Inc.
First posted: 2019-11-06
Enrollment: 133
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: rTNSS Responder Rate
timeFrame: 90-days post treatment
Secondary outcomes:
measure: rTNSS Responder Rate
timeFrame: Through 12 months post treatment
measure: Change in Total RQLQ(S)
timeFrame: Through 12 months post treatment
measure: Patient Satisfaction Questionnaire
timeFrame: Through 12 months post treatment
measure: Serious Device- and/or Procedure-related Adverse Events
timeFrame: Through 12 months post procedure
Other outcomes:
Locations:
city: Coral Springs
country: United States
facility: ENT Associates of South Florida
state: Florida
Study officials:
affiliation: Ichan School of Medicine, Mount Sinai, New York, NY
name: Anthony DelSignore, MD
role: PRINCIPAL_INVESTIGATOR
References: