Chronic RhinitisNCT06128200
NEUROMARK Randomized Controlled Trial
A study testing NEUROMARK System in people with Chronic Rhinitis, run by Neurent Medical at 16 sites in United States.
Trial summary
The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial. 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?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 16 sitesUnited States
- Study dates
- 10 Oct 2023to 26 Nov 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant Must:
- Be ≥18 years of age.
- Have been experiencing rhinitis symptoms for a minimum of 6 months.
- Have moderate to severe symptoms of runny 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 baseline.
- Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
- Be willing and able to comply with all study elements, as indicated by written informed consent.
Show all 12Show fewer
- Primary Exclusion Criteria:
- Participant Must Not:
- Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
- Have had previous sinus or nasal surgery within 6 months of study enrollment.
- Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
- Have rhinitis symptoms that are due to seasonal allergies only.
Who cannot join
None listed.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Ascension St. Vincent
Anderson, Indiana, 46016
Centers for Advanced ENT Care
Baltimore, Maryland, 21204
Bethlehem ENT
Bethlehem, Pennsylvania, 18017
ENT & Allergy Associates of Florida
Boynton Beach, Florida, 33426
ExcelENT
Homewood, Alabama, 35204
Houston Methodist ENT Specialists
Houston, Texas, 77030
Sensa Health
Los Angeles, California, 90006
Kentuckiana
Louisville, Kentucky, 40205
Advanced ENT & Allergy
Louisville, Kentucky, 40220
The ENT & Allergy Centers of Texas
McKinney, Texas, 75708
East Alabama ENT
Opelika, Alabama, 36801
ENT & Allergy Associates of Florida
Port Saint Lucie, Florida, 34952
ENT & Allergy Associates
Puyallup, Washington, 98374-1145
Richmond ENT
Richmond, Virginia, 23235
Sacramento ENT
Sacramento, California, 95815
Breathe Clear Institute
Torrance, California, 90503
About this study
Official title: Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis
The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.
- Conditions
- Chronic Rhinitis
- Being tested
- NEUROMARK System, Sham NEUROMARK System
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.
Sham NEUROMARK SystemDevice
Sham ablation procedure using the NEUROMARK System
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Subjects in this arm will undergo treatment with the NEUROMARK device. Receives: Device: NEUROMARK System |
| Sham | Sham comparator | Subjects in this arm will undergo the procedure with a Sham device. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria. Receives: Device: Sham NEUROMARK System |
What is being measured
The primary outcome is the main question the study is designed to answer.
rTNSS
Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days
Measured: 90-days post procedure follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start10 Oct 2023
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
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
- Randomised
- Intervention model
- Crossover
- Model description
- A prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurent Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128200
- Sponsor's protocol ID
- CIP-0010
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2023
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT06128200
- Acronym / sponsor ID
- CIP-0010
- Conditions
- Chronic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Neurent MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 13 Nov 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 RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: NEUROMARK SystemSubjects in this arm will undergo treatment with the NEUROMARK device. |
| Sham | Sham comparator | Device: Sham NEUROMARK SystemSubjects in this arm will undergo the procedure with a Sham device. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be ≥18 years of age.
- Have been experiencing rhinitis symptoms for a minimum of 6 months.
- Have moderate to severe symptoms of runny 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 baseline.
- Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
- Be willing and able to comply with all study elements, as indicated by written informed consent.
Key exclusion criteria (0 listed)
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 | Active |
| Sham NEUROMARK SystemSham ablation procedure using the NEUROMARK System | Device | Sham |
Primary outcome
rTNSS
Time frame: 90-days post procedure follow-up
Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days
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 19 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
16 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 16 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 12 inclusion and 0 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. Some participants in this study may receive a placebo. 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?
rTNSS (time frame: 90-days post procedure follow-up). 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 19 Mar 2026.