Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis

NCT03181594 | Completed Results FDA Device

• 1 other identifier: CT-0003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.

Conditions

Chronic Rhinitis

Keywords

Cryotherapy; Cryoablation

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Symptom Severity

  Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference.

  90 days post treatment

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

  Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events

  90 days post treatment

Secondary Outcomes (1)

• Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

  90 days post treatment

Other Outcomes (1)

• Change From Baseline in Symptom Severity

  1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure

Study Arms (1)

Treatment with the ClariFix Device

EXPERIMENTAL

Bilateral ablation of nasal tissue for treatment of chronic rhinitis

Device: ClariFix Device

Interventions

ClariFix Device DEVICE

Cryoablation in the nasal passageway using the ClariFix Device

Treatment with the ClariFix Device

Eligibility Criteria

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

You may qualify if:

• Subject is \>21 years of age
• Subject has moderate to severe symptoms of rhinorrhea (individual symptom rating of 2 or 3), mild to severe symptoms of congestion (individual symptom rating of 1, 2 or 3) and a minimum TNSS score of 4 (out of 12) at the time of the treatment visit, which have been present for \> 6 months.
• Subject has had documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens or is willing to have one performed prior to study exit.
• Subject has been dissatisfied with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief by the subject's assessment.
• Subject has signed IRB-approved informed consent form

You may not qualify if:

• Subject has clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to septal deviation or perforation, nasal polyps, sinonasal tumor.
• Subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
• Subject has active nasal or sinus infection.
• Subject has moderate to severe ocular symptoms.
• Subject has a history of nosebleeds in the past 3 months.
• Subject has a history of rhinitis medicamentosa.
• Subject has had prior head or neck irradiation
• Subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin).
• Subject is pregnant.
• Subject is participating in another clinical research study.
• Subject has an allergy or intolerance to anesthetic agent.
• Subject has cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
• Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk.

Sponsors & Collaborators

• Arrinex, Inc.: lead

Study Sites (6)

California Sleep Institute

East Palo Alto, California, 94303, United States

Location

Sacramento Ear, Nose, and Throat

Sacramento, California, 95661, United States

Location

San Francisco Otolaryngology Medical Group

San Francisco, California, 94108, United States

Location

Ear, Nose, and Throat Associates of South Florida

Boca Raton, Florida, 33487, United States

Location

Bethlehem Ear, Nose, and Throat

Bethlehem, Pennsylvania, 18017, United States

Location

EVMS Otolaryngology

Norfolk, Virginia, 23507, United States

Location

Related Publications (2)

• Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. 2020 Aug;130(8):1877-1884. doi: 10.1002/lary.28301. Epub 2019 Sep 30.

  PMID: 31566744 RESULT

• Ow RA, O'Malley EM, Han JK, Lam KK, Yen DM. Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study. Laryngoscope. 2021 Sep;131(9):1952-1957. doi: 10.1002/lary.29453. Epub 2021 Feb 22.

  PMID: 33616224 RESULT

Results Point of Contact

• Title: Principal Clinical Research & Publications Manager
• Organization: Stryker ENT

ellen.omalley@stryker.com

763-463-1598

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: March 2, 2017
• Primary Completion: July 31, 2018
• Study Completion: April 6, 2020
• Last Updated: March 17, 2021
• Results First Posted: November 4, 2019

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)