Chronic RhinitisSNIFNCT03739216
Registry of Subject Treated With ClariFix
An observational study of Chronic Rhinitis, run by Arrinex, Inc. at 23 sites in United States.
Trial summary
A multi-center, prospective, non-randomized, observational registry to asses the results of the ClariFix(TM) device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- ClariFix
- Type of treatment
- Medical device
- How many people
- 354 participants
- Where
- 23 sitesUnited States
- Study dates
- 13 Jun 2018to 15 Jun 2021
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Physicians and staff will invite patients receiving treatment with ClariFix device and who meet enrollment criteria to participate in the registry. Invited patients who provide informed consent will be enrolled into the registry. Baseline, treatment, and follow-up data will be collected at predetermined intervals.
Who may be able to join
- Participant is scheduled to receive treatment with the ClariFix device in accordance with the ClariFix Instructions for Use.
- Participant is able to provide consent and willing to adhere to the study visit schedule.
Who cannot join
- Participant is scheduled to have additional treatment and/or procedures completed at the same time of treatment with the ClariFix device.
- Participant is scheduled to have additional nasal or sinus treatments and/or procedures completed within 3 months of treatment with the ClariFix device.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Albany ENT & Allergy
Albany, New York, 12206
Metropolitan ENT
Alexandria, Virginia, 22310
Del Rey Allergy & Sinus
Bakersfield, California, 93312
Bethlehem ENT
Bethlehem, Pennsylvania, 18017
Light ENT
Boynton Beach, Florida, 33426
Chicago Nasal & Sinus
Chicago, Illinois, 60602
Rush University Medical Center
Chicago, Illinois, 60612
North Georgia ENT
Cumming, Georgia, 30040
Texas Healthcare
Fort Worth, Texas, 76104
Collin County ENT
Frisco, Texas, 75034
UT Health
Houston, Texas, 77030
Del Rey Allergy & Sinus
Marina del Rey, California, 90292
Tandem Clinical Research
Marrero, Louisiana, 70072
ENT Associates of Texas
McKinney, Texas, 75070
Aurora Health System
Milwaukee, Wisconsin, 53215
ENT & Allergy/Northwell Health
New York, New York, 10016
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Ogden Clinic
Ogden, Utah, 84403
Ear, Nose, and Throat Associates of South Florida
Plantation, Florida, 33324
Sacramento, Ear, Nose, and Throat
Roseville, California, 95661
UC Davis Dept of Otolaryngology
Sacramento, California, 95817
Breathe Clear Institutue
Torrance, California, 90503
Piedmont ENT
Winston-Salem, North Carolina, 27103
About this study
Official title: A Prospective, Multi-Center Registry of Subjects Treated With the ClariFix Cryotherapy Device
A multi-center, prospective, non-randomized, observational registry to asses the results of the ClariFix(TM) device when used to ablate unwanted tissue in the nose of subjects with 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 is a handheld cryosurgical device which provides focal, controlled freezing to the target tissue.
| Study group | Role | What they receive |
|---|---|---|
| Open label | Open label registry study of patients treated with the ClariFix device for chronic rhinitis. Receives: Device: ClariFix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in nasal symptom severity
Effectiveness will be assessed by the change from baseline in nasal symptoms using the TNSS (Total Nasal Symptom Score). The TNSS is a patient-reported assessment of 4 symptom scores for rhinorrhea (runny nose), nasal congestion, nasal itching, and sneezing. Each symptom is rated on a scale of 0 (none) to 3 (severe). The symptom scores are summed to give a total TNSS score that can range from 0 to 12.
Measured: Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
Secondary outcomes (2)
Patient-assessed improvement in nasal symptoms
Percentage of participants reporting their change from baseline as minimally improved, much improved, or very much improved using the Patient Global Impression of Change (PGIC) assessment. The PGIC has patients evaluate their improvement over baseline on a scale from 1 (very much improved) to 7 (very much worse).
Measured: Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
Clinician-assessed improvement in nasal symptoms
Percentage of clinicians reporting their participants change in nasal symptoms from baseline as minimally improved, much improved, or very much improved using the Clinical Global Impression - Improvement (CGI-I) assessment. The CGI-I has clinicians rate their patient's improvement over baseline on a scale from 1 (very much improved) to 7 (very much worse).
Measured: Follow-up visit at 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start13 Jun 2018
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Arrinex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amber U Luong, MD, PhD, Principal investigator, UT Health - The University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739216
- Sponsor's protocol ID
- CT-0004
- Acronym
- SNIF
- Status last verified
- Jul 2021
- First submitted
- 3 Oct 2018
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Registry of Subjects Treated With the ClariFix Cryotherapy Device
- ClinicalTrials.gov ID
- NCT03739216
- Acronym / sponsor ID
- SNIF / CT-0004
- Conditions
- Chronic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Arrinex, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, prospective, non-randomized, observational registry to asses the results of the ClariFix(TM) device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | – | Device: ClariFixOpen label registry study of patients treated with the ClariFix device for chronic rhinitis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physicians and staff will invite patients receiving treatment with ClariFix device and who meet enrollment criteria to participate in the registry. Invited patients who provide informed consent will be enrolled into the registry. Baseline, treatment, and follow-up data will be collected at predetermined intervals.
Key inclusion criteria (2 listed)
- Participant is scheduled to receive treatment with the ClariFix device in accordance with the ClariFix Instructions for Use.
- Participant is able to provide consent and willing to adhere to the study visit schedule.
Key exclusion criteria (2 listed)
- Participant is scheduled to have additional treatment and/or procedures completed at the same time of treatment with the ClariFix device.
- Participant is scheduled to have additional nasal or sinus treatments and/or procedures completed within 3 months of treatment with the ClariFix device.
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 is a handheld cryosurgical device which provides focal, controlled freezing to the target tissue. | Device | Open label |
Primary outcome
Change from baseline in nasal symptom severity
Time frame: Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
Effectiveness will be assessed by the change from baseline in nasal symptoms using the TNSS (Total Nasal Symptom Score). The TNSS is a patient-reported assessment of 4 symptom scores for rhinorrhea (runny nose), nasal congestion, nasal itching, and sneezing. Each symptom is rated on a scale of 0 (none) to 3 (severe). The symptom scores are summed to give a total TNSS score that can range from 0 to 12.
2 secondary outcomes
Patient-assessed improvement in nasal symptoms
Time frame: Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
Clinician-assessed improvement in nasal symptoms
Time frame: Follow-up visit at 3 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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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.
Amber U Luong, MD, PhD principal investigator
UT Health - The University of Texas
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinitis, run by Arrinex, Inc. at 23 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 2 inclusion and 2 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 nasal symptom severity (time frame: Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months 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 3 Aug 2021.