Chronic RhinitisCR RCTNCT04154605
ClariFix Rhinitis RCT
A study testing ClariFix cryotherapy in people with Chronic Rhinitis, run by Stryker Instruments at 1 site in United States.
Trial summary
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- ClariFix cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to 19 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
ENT Associates of South Florida
Coral Springs, Florida, 33065
About this study
Official title: ClariFix Rhinitis Randomized Controlled Trial
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.
Read the 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
- Being tested
- ClariFix cryotherapy, Sham ClariFix cryotherapy
- Keywords
- Cryotherapy, Cryoablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClariFix cryotherapyDevice
Bilateral freeze ablation of nasal tissue using the ClariFix device.
Sham ClariFix cryotherapyDevice
Also called Sham
Bilateral sham ablation procedure using the ClariFix device.
| Study group | Role | What they receive |
|---|---|---|
| ClariFix | Active comparator | Cryotherapy of the nasal passages with the ClariFix device. Receives: Device: ClariFix cryotherapy |
| Sham | Sham comparator | Sham cryotherapy of the nasal passages with the ClariFix device Receives: Device: Sham ClariFix cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90-days post treatment
Secondary outcomes (4)
rTNSS Responder Rate
Mean change from baseline in the rTNSS. 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.
Measured: Through 12 months post treatment
Change in Total RQLQ(S)
Mean change from baseline in the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) score.
The RQLQ(S) is a validated PRO that measures functional impairments due to allergic or non-allergic rhinoconjunctivitis. The assessment consists of 28 questions related to nose symptoms, eye symptoms, non-eye/nose symptoms, sleep problems, practical problems, activity limitations, and emotional function. Each item is scored from 0 (no impairment) to 6 (severely impaired). An overall score is calculated from the mean of the 28 item responses. Domain scores are the mean of the item scores within that domain.
Measured: Through 12 months post treatment
Patient Satisfaction Questionnaire
Percent of participants indicating satisfaction with the procedure outcome. The satisfaction questionnaire consists of 3 questions that the participant answers at each follow-up visit. The questions indicate whether the participant is satisfied with the procedure outcome, whether the participant would undergo the procedure again for similar results, and whether the participant would recommend the procedure to family or friends with a similar condition. For each item the participant indicates agreement/disagreement with each statement.
Measured: Through 12 months post treatment
Serious Device- and/or Procedure-related Adverse Events
The number of participants with one or more serious adverse events that are possibly, probably, or definitely related to the ClariFix device and/or procedure.
Measured: Through 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start5 Nov 2019
- Primary completion31 Mar 2021
- Study completion19 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Instruments
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Inc.
- Responsible party
- Sponsor
- Investigators
- Anthony DelSignore, MD, Principal investigator, Ichan School of Medicine, Mount Sinai, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154605
- Sponsor's protocol ID
- 4666-001
- Acronym
- CR RCT
- Status last verified
- Mar 2025
- First submitted
- 31 Oct 2019
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClariFix Rhinitis Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04154605
- Acronym / sponsor ID
- CR RCT / 4666-001
- Conditions
- Chronic Rhinitis
- Keywords
- Cryotherapy, Cryoablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Stryker InstrumentsIndustry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Inc.
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 19 Jan 2025 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Posted 20 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ClariFix | Active comparator | Device: ClariFix cryotherapyCryotherapy of the nasal passages with the ClariFix device. |
| Sham | Sham comparator | Device: Sham ClariFix cryotherapySham cryotherapy of the nasal passages with the ClariFix device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClariFix cryotherapyBilateral freeze ablation of nasal tissue using the ClariFix device. | Device | ClariFix |
| Sham ClariFix cryotherapyAlso: ShamBilateral sham ablation procedure using the ClariFix device. | Device | Sham |
Primary outcome
rTNSS Responder Rate
Time frame: 90-days post treatment
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.
4 secondary outcomes
rTNSS Responder Rate
Time frame: Through 12 months post treatment
Change in Total RQLQ(S)
Time frame: Through 12 months post treatment
Patient Satisfaction Questionnaire
Time frame: Through 12 months post treatment
Serious Device- and/or Procedure-related Adverse Events
Time frame: Through 12 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony DelSignore, MD principal investigator
Ichan School of Medicine, Mount Sinai, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClariFix cryotherapy in people with Chronic Rhinitis, run by Stryker Instruments at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rTNSS Responder Rate (time frame: 90-days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.