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Completed

NCT Number: NCT03181594

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

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.

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Key information

Conditions

Chronic Rhinitis

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Sleep Institute, East Palo Alto, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

ClariFix Device

Device

Cryoablation in the nasal passageway using the ClariFix Device

Primary outcomes

  1. Change From Baseline in Symptom Severity

    Time frame: 90 days post treatment

    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.

  2. Device- and/or Procedure-related Serious Adverse Events

    Time frame: 90 days post treatment

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

Secondary outcomes

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

    Time frame: 90 days post treatment

    The RQLQ is a validated quality of life questionnaire that evaluates functional problems associated with rhinitis. The questionnaire assess 7 domains: activities, sleep, nose symptoms, eye symptoms, non nose/eye symptoms, practical problems, and emotional function. Each question is scores on a 7-point scale (0=not impaired at all, 6=severely impaired). A domain and total scores are based on the mean of all answered items in that domain resulting in domain or total scores ranging from 0 to 6. An average change on 0.5 or more is considered a minimal clinically important difference.

Other outcomes

  1. Change From Baseline in Symptom Severity

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

    Median 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 point or more is considered the minimum clinically important difference.

Sponsors and collaborators

Lead sponsor

Arrinex, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis

Acronym: FROST

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jun 9, 2017
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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