ClariFix Rhinitis RCT

NCT ID: NCT04154605

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2025-01-19

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.

Conditions

Chronic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ClariFix

Cryotherapy of the nasal passages with the ClariFix device.

Group Type: ACTIVE_COMPARATOR

ClariFix cryotherapy

Intervention Type: DEVICE

Bilateral freeze ablation of nasal tissue using the ClariFix device.

Sham

Sham cryotherapy of the nasal passages with the ClariFix device

Group Type: SHAM_COMPARATOR

Sham ClariFix cryotherapy

Intervention Type: DEVICE

Bilateral sham ablation procedure using the ClariFix device.

Interventions

ClariFix cryotherapy

Bilateral freeze ablation of nasal tissue using the ClariFix device.

Intervention Type: DEVICE

Sham ClariFix cryotherapy

Bilateral sham ablation procedure using the ClariFix device.

Intervention Type: DEVICE

Other Intervention Names

Sham

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North American Science Associates Inc.

UNKNOWN

Sponsor Role: collaborator

Stryker Instruments

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony DelSignore, MD

Role: PRINCIPAL_INVESTIGATOR

Ichan School of Medicine, Mount Sinai, New York, NY

Locations

ENT Associates of South Florida

Coral Springs, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

4666-001

Identifier Type: -

Identifier Source: org_study_id