ClariFix Rhinitis RCT

NCT04154605 | Completed Results FDA Device

• 1 other identifier: 4666-001
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Rhinitis

Keywords

Cryotherapy; Cryoablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• rTNSS Responder Rate

  Through 12 months post treatment

• Change in Total RQLQ(S)

  Through 12 months post treatment

• Patient Satisfaction Questionnaire

  Through 12 months post treatment

• Serious Device- and/or Procedure-related Adverse Events

  Through 12 months post procedure

Study Arms (2)

ClariFix

ACTIVE COMPARATOR

Cryotherapy of the nasal passages with the ClariFix device.

Device: ClariFix cryotherapy

Sham

SHAM COMPARATOR

Sham cryotherapy of the nasal passages with the ClariFix device

Device: Sham ClariFix cryotherapy

Interventions

ClariFix cryotherapy DEVICE

Bilateral freeze ablation of nasal tissue using the ClariFix device.

ClariFix

Sham ClariFix cryotherapy DEVICE

Bilateral sham ablation procedure using the ClariFix device.

Also known as: Sham

Sham

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Instruments: lead
• North American Science Associates Inc.: collaborator

Study Sites (1)

ENT Associates of South Florida

Coral Springs, Florida, 33065, United States

Location

Limitations and Caveats

Study follow up is ongoing. Only 90 day endpoints are available currently.

Results Point of Contact

• Title: Robyn Schacherer, Manager Clinical Affairs
• Organization: Stryker

robyn.schacherer@stryker.com

763-463-7054

Study Officials

• Anthony DelSignore, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants will be blinded to treatment assignment from procedure through their 90-day visit.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 6, 2019
• Study Start: November 5, 2019
• Primary Completion: March 31, 2021
• Study Completion: January 19, 2025
• Last Updated: March 26, 2025
• Results First Posted: September 20, 2021

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)