Chronic RhinitisNCT05937308
NEUROMARK Registry Study
A study testing NEUROMARK System in people with Chronic Rhinitis, run by Neurent Medical at 9 sites in United States.
Trial summary
The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects with 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?
- NEUROMARK System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Jun 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject MUST:
- Be ≥18 years of age.
- Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
- Have moderate to severe symptoms of running nose (individual 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 score of 5 (out of 12) at screening.
- Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.
Who cannot join
- Subjects Must Not:
- 1. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Metropolitan ENT
Alexandria, Virginia, 22310
Alabama Nasal & Sinus Center
Birmingham, Alabama, 35242
Florida ENT & Allergy
Brandon, Florida, 33511
Sensa Health
Los Angeles, California, 90006
Kentuckiana ENT
Louisville, Kentucky, 40205
ENT & Allergy Texas
McKinney, Texas, 75071
Ogden Clinic
Ogden, Utah, 84403
Sacramento ENT
Roseville, California, 95661
Breathe Clear Institute
Torrance, California, 90503
About this study
Official title: Interventional Registry to Collect Real-World Evidence of the NEUROMARK System in Subjects With Chronic Rhinitis
The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects with chronic rhinitis.
- Conditions
- Chronic Rhinitis
- Being tested
- NEUROMARK System
- Keywords
- Rhinitis
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROMARK SystemDevice
The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.
| Study group | Role | What they receive |
|---|---|---|
| NEUROMARK Treatment | Other | Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System. Receives: Device: NEUROMARK System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Measured: 3-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Measured: 6-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Measured: 12-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Measured: 18-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Measured: 24-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Measured: 30-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Measured: 36-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Measured: 3-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Measured: 6-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Measured: 12-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Measured: 18-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Measured: 24-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Measured: 30-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Measured: 36-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start12 Jun 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Prospective, Multicenter, Single-arm, Post-market Interventional Registry. Collect real-world evidence.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurent Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annalise Sorensen, Study director, Neurent Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937308
- Sponsor's protocol ID
- CIP-0008
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Registry to Collect Real-World Evidence of the NEUROMARK System in Subjects With Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT05937308
- Acronym / sponsor ID
- CIP-0008
- Conditions
- Chronic Rhinitis
- Keywords
- Rhinitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Neurent MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Jul 2023 (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.
The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects with chronic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Prospective, Multicenter, Single-arm, Post-market Interventional Registry. Collect real-world evidence.
| Arm | Type | Receives |
|---|---|---|
| NEUROMARK Treatment | Other | Device: NEUROMARK SystemInterventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be ≥18 years of age.
- Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
- Have moderate to severe symptoms of running nose (individual 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 score of 5 (out of 12) at screening.
- Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.
Key exclusion criteria (2 listed)
- 1. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) 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 |
|---|---|---|
| NEUROMARK SystemThe NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. | Device | NEUROMARK Treatment |
Primary outcome
Safety - incidence of device- and/or procedure-related serious adverse
Time frame: 3-month follow-up
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Time frame: 6-month follow-up
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Time frame: 12-month follow-up
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Time frame: 18-month follow-up
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Time frame: 24-month follow-up
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Time frame: 30-month follow-up
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Time frame: 36-month follow-up
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Time frame: 3-month follow-up
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Time frame: 6-month follow-up
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Time frame: 12-month follow-up
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Time frame: 18-month follow-up
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Time frame: 24-month follow-up
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Time frame: 30-month follow-up
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Time frame: 36-month follow-up
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
Annalise Sorensen study director
Neurent Medical
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEUROMARK System in people with Chronic Rhinitis, run by Neurent Medical at 9 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 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety - incidence of device- and/or procedure-related serious adverse (time frame: 3-month follow-up). The study lists 14 primary outcomes in all. 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 12 Aug 2026.