RhinitisNCT02820597

ClariFix Cryoablation Clinical Study

A study testing ClariFix device in people with Rhinitis, run by Arrinex, Inc..

Completed

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

Trial summary

This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: 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: 27 participants
Where: No sites listed yet
Study dates: 15 Jun 2015to 20 Jul 2016
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 had moderate to severe symptoms of rhinorrhea and/or nasal congestion for >3 months (rTNSS rating of 2 or 3)
Subject has signed IRB-approved informed consent form

Who cannot join

Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
Subject has a septal perforation
Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
Subject has had prior head or neck irradiation
Subject has active or chronic nasal or sinus infection
Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks

Show all 12Show fewer

Subject has a history of dry nose symptoms
Subject is pregnant or lactating
Subject is participating in another clinical research study
Subject has an allergy or intolerance to anesthetic agent
Subject is an active smoker or has been a smoker within the last 6 months
Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk

About this study

Official title: Clinical Evaluation of Cryotherapy in the Nasal Passageway Using the ClariFix Device

This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.

Read the detailed description

This is a small, prospective, multicenter, single-arm, self-controlled interventional feasibility study to evaluation cryoablation in the nasal passage as a treatment for chronic rhinitis. The ClariFix device is FDA-cleared device with the intended use for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

Conditions: Rhinitis
Being tested: ClariFix device
Medical subject headings: Rhinitis

What participants receive

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

ClariFix deviceDevice

Study groups in NCT02820597
Study group	Role	What they receive
Intervention	Experimental	Cryoablation with the ClariFix device Receives: Device: ClariFix device

What is being measured

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

Device- and/or Procedure-related Serious Adverse Events
Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.
Measured: Baseline through 365 days post treatment
Change in Rhinitis Symptom Severity (rTNSS)
Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours.
Measured: Baseline through 365 days post treatment
Change in Rhinitis Symptoms (VAS)
Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10.
Measured: Baseline through 365 days post treatment

Secondary outcomes (2)

Ease of Use
Physician evaluation of ClariFix ease of use. After each participant's treatment, the physician was asked to rate the ClariFix on ease of use. Options were easy, moderately easy, moderately difficult, or difficult.
Measured: Immediately post treatment
Device- and/or Procedure-related Adverse Events
All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.
Measured: Baseline through 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.

15 Jun 201520 Jul 2016

First posted1 Jul 2016 (estimated)
Study start15 Jun 2015
Primary completion5 Feb 2016
Study completion20 Jul 2016

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 (1)Papers the sponsor has linked to this study.
Other trials for 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: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02820597
Sponsor's protocol ID: A2014-02
Status last verified: Oct 2019
First submitted: 29 Jun 2016
Last updated: 21 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Hwang PH, Lin B, Weiss R, Atkins J, Johnson J. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. 2017 Oct;7(10):952-956. doi: 10.1002/alr.21991. Epub 2017 Aug 11.
PubMed 28799727

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?

Official record

Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
Not yet recruitingObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children

All Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Cryotherapy in the Nasal Passageway Using the ClariFix Device
ClinicalTrials.gov ID: NCT02820597
Acronym / sponsor ID: A2014-02
Conditions: Rhinitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Arrinex, Inc.Industry (pharma, biotech, devices)
Study start: 15 Jun 2015 (actual)
Primary completion: 5 Feb 2016 (actual)
Study completion: 20 Jul 2016 (actual)
First posted: 1 Jul 2016 (estimated)
Results: Posted 21 Oct 2019

Clinical summary

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

This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.

Detailed description

Study design

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

Arm	Type	Receives
Intervention	Experimental	Device: ClariFix deviceCryoablation 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 (3 listed)

Subject is >21 years of age
Subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion for >3 months (rTNSS rating of 2 or 3)
Subject has signed IRB-approved informed consent form

Key exclusion criteria (12 listed)

Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
Subject has a septal perforation
Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
Subject has had prior head or neck irradiation
Subject has active or chronic nasal or sinus infection

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 device	Device	Intervention

Primary outcome

Device- and/or Procedure-related Serious Adverse Events
Time frame: Baseline through 365 days post treatment
Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.
Change in Rhinitis Symptom Severity (rTNSS)
Time frame: Baseline through 365 days post treatment
Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours.
Change in Rhinitis Symptoms (VAS)
Time frame: Baseline through 365 days post treatment
Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10.

2 secondary outcomes

Ease of Use
Time frame: Immediately post treatment
Device- and/or Procedure-related Adverse Events
Time frame: Baseline through 90 days post treatment

Results and safety

Results posted to the registry on 21 Oct 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
Intervention	27	15

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

Time frame: Baseline through 365 days post treatment. Number. Unit: participants

Measure	Intervention n = 27
Value	0

Population analysed: A total of 27 subjects were enrolled and received bilateral cryosurgery with the ClariFix device (n=54 treatments).

Primary outcome: Change in Rhinitis Symptom Severity (rTNSS)

Time frame: Baseline through 365 days post treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention n = 27
7 Days post treatment	-1.9 (0.6)
30 Days post treatment	-3.6 (0.6)
90 Days post treatment	-3.3 (0.6)
180 Days post treatment	-4.0 (0.5)
365 Days post treatment	-4.5 (0.3)

Intervention: p <0.001, t-test, 2 sided

Population analysed: All participants with follow-up at the indicated visits.

Primary outcome: Change in Rhinitis Symptoms (VAS)

Time frame: Baseline through 365 days post treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention n = 27
7 Days post treatment	-2.1 (0.5)
30 Days post treatment	-3.8 (0.5)
90 Days post treatment	-4.1 (0.6)
180 Days post treatment	-2.9 (0.7)
365 Days post treatment	-5.6 (1.1)

Intervention: p <0.001, t-test, 2 sided

Population analysed: All treated participants with follow-up at the indicated visits.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 Year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 27 (0%)	19 of 27 (70.4%)	0 of 27

Limitations and caveats (from the sponsor): This is a feasibility study based on a small population of participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28799727Hwang PH, Lin B, Weiss R, Atkins J, Johnson J. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. 2017 Oct;7(10):952-956. doi: 10.1002/alr.21991. Epub 2017 Aug 11.
Individual participant dataSharing planned: No

Related trials for Rhinitis

Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
Not yet recruitingObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children

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.

Jacob Johnson, MD principal investigator

San Francisco Otolaryngology Medical Group

Questions about this trial

What is this clinical trial studying?

A study testing ClariFix device in people with Rhinitis, run by Arrinex, Inc..

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 3 inclusion and 12 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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

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 21 Oct 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?

Device- and/or Procedure-related Serious Adverse Events (time frame: Baseline through 365 days post treatment). The study lists 3 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 NCT02820597, which also lists 1 linked publication.

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 21 Oct 2019.