Chronic RhinitisFROSTNCT03181594

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

A study testing ClariFix Device in people with Chronic Rhinitis, run by Arrinex, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. 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 Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 6 sitesUnited States
Study dates: 2 Mar 2017to 6 Apr 2020
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

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

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Bethlehem Ear, Nose, and Throat
Bethlehem, Pennsylvania, 18017
Ear, Nose, and Throat Associates of South Florida
Boca Raton, Florida, 33487
California Sleep Institute
East Palo Alto, California, 94303
EVMS Otolaryngology
Norfolk, Virginia, 23507
Sacramento Ear, Nose, and Throat
Sacramento, California, 95661
San Francisco Otolaryngology Medical Group
San Francisco, California, 94108

Other trials in United States

About this study

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

Conditions: Chronic Rhinitis
Being tested: ClariFix Device
Keywords: Cryotherapy, Cryoablation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClariFix DeviceDevice
Cryoablation in the nasal passageway using the ClariFix Device

Study groups in NCT03181594
Study group	Role	What they receive
Treatment with the ClariFix Device	Experimental	Bilateral ablation of nasal tissue for treatment of chronic rhinitis Receives: Device: ClariFix Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 90 days post treatment

Secondary outcomes (1)

Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
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.
Measured: 90 days post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20176 Apr 2020

First posted9 Jun 2017
Study start2 Mar 2017
Primary completion31 Jul 2018
Study completion6 Apr 2020

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.
Publications (2)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03181594
Sponsor's protocol ID: CT-0003
Acronym: FROST
Status last verified: Feb 2021
First submitted: 7 Jun 2017
Last updated: 17 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 31566744
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.
PubMed 33616224

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
ClinicalTrials.gov ID: NCT03181594
Acronym / sponsor ID: FROST / CT-0003
Conditions: Chronic Rhinitis
Keywords: Cryotherapy, Cryoablation
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Arrinex, Inc.Industry (pharma, biotech, devices)
Study start: 2 Mar 2017 (actual)
Primary completion: 31 Jul 2018 (actual)
Study completion: 6 Apr 2020 (actual)
First posted: 9 Jun 2017 (actual)
Results: Posted 4 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment with the ClariFix Device	Experimental	Device: ClariFix DeviceBilateral ablation of nasal tissue for treatment of chronic rhinitis

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (13 listed)

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.

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 DeviceCryoablation in the nasal passageway using the ClariFix Device	Device	Treatment with the ClariFix Device

Primary outcome

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.
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

1 secondary outcome

Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: 90 days post treatment

Results and safety

Results posted to the registry on 4 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With the ClariFix Device	100	91

Primary outcome: Change From Baseline in Symptom Severity

Time frame: 90 days post treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment With the ClariFix Device n = 98
Value	-3.1 (2.6)

Treatment With the ClariFix Device: p <0.001, t-test, 2 sided

Population analysed: All treated participants with 90-day follow-up.

Primary outcome: Device- and/or Procedure-related Serious Adverse Events

Time frame: 90 days post treatment. Number. Unit: events

Measure	Treatment With the ClariFix Device n = 100
Value	1

Population analysed: All treated participants.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events from procedure through 9 months post treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With the ClariFix Device	9 of 100 (9%)	0 of 100 (0%)	4 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31566744Chang 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.
Results publication: PubMed 33616224Ow 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.
Individual participant dataSharing planned: No

Related trials for Chronic Rhinitis

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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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ClariFix Device in people with Chronic Rhinitis, run by Arrinex, Inc. at 6 sites 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 5 inclusion and 13 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. 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 4 Nov 2019). 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?

Change From Baseline in Symptom Severity (time frame: 90 days post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03181594, which also lists 2 linked publications.

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 17 Mar 2021.