Chronic RhinitisNCT03791489
Multi-Treatment PNN Modulation for Chronic Rhinitis
A study testing ClariFix in people with Chronic Rhinitis, run by Arrinex, Inc. at 3 sites in United States.
Trial summary
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- ClariFix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2018to 18 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for >3 months.
- 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.
- Able to provide informed consent and willing to complete study activities and visits per protocol.
Who cannot join
- Clinically significant anatomic obstructions that limit access to the posterior nose.
- Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
- Moderate to severe ocular symptoms as determined.
- History of epistaxis in the past 3 months.
- History of rhinitis medicamentosa.
- Prior head or neck irradiation.
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- Active or chronic nasal or sinus infection.
- Pregnant.
- Allergy or intolerance to anesthetic agent.
- Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
- Currently participating in another clinical research study.
- Any physical condition that, in the investigator's opinion, would prevent adequate study participation or pose increased risk.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bethlehem ENT
Bethlehem, Pennsylvania, 18017
Tracy Byerly, MD
Fredericksburg, Texas, 78624
San Francisco Otolaryngology Medical Group
San Francisco, California, 94108
About this study
Official title: Feasibility Study of Multi-Treatment Posterior Nasal Nerve (PNN) Modulation for Treatment of Chronic Rhinitis
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
- Conditions
- Chronic Rhinitis
- Being tested
- ClariFix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClariFixDevice
The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Cryotherapy of the posterior nasal nerve using the ClariFix device Receives: Device: ClariFix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)
The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.
Measured: Study duration (90-days)
Secondary outcomes (3)
Pain Scores
Tolerability of treatment as provided by the participant by verbal report of pain/discomfort during treatment and post treatment using an 11-point scale indicating pain intensity from 0 (no pain) to 10 (worst pain).
Measured: Day of treatment during procedure and for up to 1 hour post procedure
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
The rTNSS is a validated patient-reported outcome measure consisting of 4 symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. Each item is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). The total rTNSS is the sum of the 4 symptom scores and has a possible range of 0 to 12 points. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.
Measured: 30 and 90 days after treatment
Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score
The NOSE survey is a patient-reported outcome measure consisting of 5 nasal symptoms: nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through the nose, trouble sleeping, and unable to get enough air through the nose during exercise or exertion. Each symptom is scored using a 5-point scale of 0 (not a problem) to 4 (severe problem). The 5 symptom scores are summed and the total is multiplied by 5 to give a total score that ranges from 0 to 100, with higher scores indicating worse symptoms. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.
Measured: 30 and 90 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Dec 2018
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, feasibility study of multi-treatment locations
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrinex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Yen, MD, Principal investigator, Specialty Physician Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791489
- Sponsor's protocol ID
- CT-0005
- Status last verified
- Jul 2020
- First submitted
- 31 Dec 2018
- Last updated
- 24 Jul 2020
- 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 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Multi-Treatment Posterior Nasal Nerve (PNN) Modulation for Treatment of Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT03791489
- Acronym / sponsor ID
- CT-0005
- Conditions
- Chronic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Arrinex, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Posted 24 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, feasibility study of multi-treatment locations
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Device: ClariFixCryotherapy of the posterior nasal nerve using the ClariFix device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for >3 months.
- 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.
- Able to provide informed consent and willing to complete study activities and visits per protocol.
Key exclusion criteria (12 listed)
- Clinically significant anatomic obstructions that limit access to the posterior nose.
- Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
- Moderate to severe ocular symptoms as determined.
- History of epistaxis in the past 3 months.
- History of rhinitis medicamentosa.
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 |
|---|---|---|
| ClariFixThe ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis. | Device | Active Treatment |
Primary outcome
Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)
Time frame: Study duration (90-days)
The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.
3 secondary outcomes
Pain Scores
Time frame: Day of treatment during procedure and for up to 1 hour post procedure
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
Time frame: 30 and 90 days after treatment
Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score
Time frame: 30 and 90 days after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- 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.
David Yen, MD principal investigator
Specialty Physician Associates
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClariFix in people with Chronic Rhinitis, run by Arrinex, Inc. at 3 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 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 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 24 Jul 2020). 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?
Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE) (time frame: Study duration (90-days)). 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 24 Jul 2020.