Chronic RhinitisNCT05324397

Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis (CLARITY)

A study testing NEUROMARK System in people with Chronic Rhinitis, run by Neurent Medical at 4 sites in United States.

Completed

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

Trial summary

The CLARITY Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical 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: 36 participants
Where: 4 sitesUnited States
Study dates: 14 Mar 2022to 4 Oct 2023
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

Subject provides written informed consent, including authorization to release health information.
Subject is 18 years of age or older at the time of consent.
Subject has provided a negative pregnancy test (if subject is a woman of childbearing potential (WOCBP).
Subject WOCBP must be practicing and willing to continue an effective method of birth control during the course of the study.
Confirmation of moderate to severe symptoms of rhinorrhea. (VAS NSS score for runny nose ≥ 5.0 and rTNSS score for runny nose ≥ 2).
Confirmation of mild to severe symptoms of nasal congestion. (VAS NSS score ≥ 2.5 for stuffy nose (congestion) and rTNSS score of ≥ 1).

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Confirmation that the total combined VAS NSS score is ≥ 10 for nasal congestion and runny nose.
Subjects stated willingness to comply with all study procedures, post- treatment care and availability for the duration of the study follow up of 1 year.
Subject tests negative for active COVID-19 at the start of study screening and continues to be free from COVID-19 symptoms until the time of enrollment/treatment.
Subject understands and agrees to follow local COVID-19 restrictions (social distancing, face mask, etc.).
Nasal anatomy appropriate to receive the NEUROMARK™ System.
Subject is experiencing long term chronic rhinitis. Subject has been experiencing symptoms of rhinitis for at least 6 months prior to enrollment, defined as: rhinorrhea, anterior runny nose AND congestion, blockage (stuffy nose, obstruction).

Who cannot join

Subject has clinically significant anatomic obstruction that limits access to the posterior nose as determined by the Study Investigator such as severe septal deviation, prior surgical considerations, cleft palate, nasal polyps, or sino-nasal tumor.
Subject has an active nasal or sinus infection at the time of treatment.
Subject has a diagnosis of Atrophic Rhinitis.
Subject has a Lund-Mackay score >3 during the screening phase, an active history of chronic sinusitis (within the last year).
Subject has a septal perforation or nasal mucosal erosion/ulceration.
Subject experiences numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sino-nasal anatomy.

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Subject has had prior sinus or nasal surgery that may prevent access or proper placement of the NEUROMARK™ System.
Subject has had prior head or neck irradiation (head/neck cancer therapy).
Subject has an allergy or intolerance to anaesthetic agent or other study-required materials.
Subject is taking anticoagulant medication or 325 mg aspirin that cannot be discontinued before the procedure and for the length of the study.
Subject has a history of nasal manifestation of rheumatic disease.
Subject has started a new sino-nasal medication regimen within 4 weeks prior to treatment (i.e. antihistamines, cromolyn, leukotriene receptor antagonists, inhaled or systemic steroids, anticholinergics, expectorants, decongestants) that, per the manufacturer's labelling, has not yet stabilized.
Subject has uncontrolled Hypothyroidism.
Subject has uncontrolled Hypertension (stage 2 or higher).
Subject is an active smoker or has been a smoker within the last 6 months (patient reported).
Any physical condition that in the Investigator's opinion would prevent adequate study participation or pose increased risk to the study Subject.
Subject is pregnant, nursing or plans to become pregnant during the study, or is a WOCBP, but is not willing to use an effective method of birth control.
Patient is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the Investigator would interfere with the study results.
Patient presents with any condition or situation which, in the Investigator's opinion, puts the Subject at risk, could confound the study results, or may interfere significantly with the Subject's participation in the study.
Subject presents with acute sinusitis at time of treatment or other sino-nasal related illness other than rhinitis.
Subject has history of chronic epistaxis or nosebleed episodes within the last 12 months.
Subject has rhinitis symptoms due to seasonal allergies only.
Subject has received previous procedure or surgery for chronic rhinitis and/or to disrupt the posterior nasal nerve.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Centers for Advanced ENT Care
Baltimore, Maryland, 21204
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
Alabama Nasal and Sinus Center
Birmingham, Alabama, 35242
ENT & Allergy Associcates
Puyallup, Washington, 98374

Other trials in United States

About this study

Official title: Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis - A Prospective, Single-arm, Multicenter Clinical Study

The CLARITY Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical 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 groups in NCT05324397
Study group	Role	What they receive
Experimental: Treatment	Experimental	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.

Number of Participants With Device- or Procedure-related Serious Adverse Events (SAEs) Within 1 Month
SAEs were defined per ICH-GCP (E6). This measure includes all SAEs assessed by the investigator as related to the device and/or procedure within 1 month post-procedure.
Measured: 1 month
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Rhinorrhea at 3 Months
The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for [rhinorrhea]. A negative change from baseline indicates improvement.
Measured: 3 months
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Nasal Congestion at 3 Months
The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for [nasal congestion]. A negative change from baseline indicates improvement.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 20224 Oct 2023

First posted12 Apr 2022
Study start14 Mar 2022
Primary completion4 Oct 2023
Study completion4 Oct 2023

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 (2)Papers the sponsor has linked to this study.
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, single-arm, multicenter clinical study
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05324397
Sponsor's protocol ID: CIP-0006
Status last verified: Aug 2026
First submitted: 4 Apr 2022
Last updated: 3 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Reh DD, Lay K, Davis G, Dubin MG, Yen DM, O'Malley EM, Sillers M. Long-term outcomes following impedance-controlled radiofrequency ablation for the treatment of chronic rhinitis. Laryngoscope Investig Otolaryngol. 2024 Jun 4;9(3):e1286. doi: 10.1002/lio2.1286. eCollection 2024 Jun.
PubMed 38835333
Reh DD, Lay K, Davis G, Dubin MG, Yen DM, O'Malley EM, Sillers M. Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis. Laryngoscope Investig Otolaryngol. 2023 Mar 16;8(2):367-372. doi: 10.1002/lio2.1040. eCollection 2023 Apr.
PubMed 37090860

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?

See locations

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All Chronic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis - A Prospective, Single-arm, Multicenter Clinical Study
ClinicalTrials.gov ID: NCT05324397
Acronym / sponsor ID: CIP-0006
Conditions: Chronic Rhinitis
Keywords: Rhinitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Neurent MedicalIndustry (pharma, biotech, devices)
Study start: 14 Mar 2022 (actual)
Primary completion: 4 Oct 2023 (actual)
Study completion: 4 Oct 2023 (actual)
First posted: 12 Apr 2022 (actual)
Results: Posted 8 Jun 2026

Clinical summary

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

The CLARITY Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical 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, single-arm, multicenter clinical study

Arm	Type	Receives
Experimental: Treatment	Experimental	Device: NEUROMARK SystemSubjects 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 (12 listed)

Subject provides written informed consent, including authorization to release health information.
Subject is 18 years of age or older at the time of consent.
Subject has provided a negative pregnancy test (if subject is a woman of childbearing potential (WOCBP).
Subject WOCBP must be practicing and willing to continue an effective method of birth control during the course of the study.
Confirmation of moderate to severe symptoms of rhinorrhea. (VAS NSS score for runny nose ≥ 5.0 and rTNSS score for runny nose ≥ 2).

Key exclusion criteria (23 listed)

Subject has clinically significant anatomic obstruction that limits access to the posterior nose as determined by the Study Investigator such as severe septal deviation, prior surgical considerations, cleft palate, nasal polyps, or sino-nasal tumor.
Subject has an active nasal or sinus infection at the time of treatment.
Subject has a diagnosis of Atrophic Rhinitis.
Subject has a Lund-Mackay score >3 during the screening phase, an active history of chronic sinusitis (within the last year).
Subject has a septal perforation or nasal mucosal erosion/ulceration.

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	Experimental: Treatment

Primary outcome

Number of Participants With Device- or Procedure-related Serious Adverse Events (SAEs) Within 1 Month
Time frame: 1 month
SAEs were defined per ICH-GCP (E6). This measure includes all SAEs assessed by the investigator as related to the device and/or procedure within 1 month post-procedure.
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Rhinorrhea at 3 Months
Time frame: 3 months
The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for [rhinorrhea]. A negative change from baseline indicates improvement.
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Nasal Congestion at 3 Months
Time frame: 3 months
The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for [nasal congestion]. A negative change from baseline indicates improvement.

Results and safety

Results posted to the registry on 8 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NEUROMARK Treatment	36	35

Primary outcome: Number of Participants With Device- or Procedure-related Serious Adverse Events (SAEs) Within 1 Month

Time frame: 1 month. Count of participants. Unit: Participants

Measure	NEUROMARK Treatment n = 36
Value	0

Primary outcome: Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Rhinorrhea at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: Score

Measure	NEUROMARK Treatment n = 36
3 Month Change	-4.1 (3.5)
Baseline	7.8 (1.6)
3 Month Follow Up	3.7 (2.7)

Primary outcome: Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Nasal Congestion at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: Score

Measure	NEUROMARK Treatment n = 36
3 Month Change	-3.9 (2.2)
Baseline	7.1 (2.1)
3 Month Follow Up	3.2 (2.0)

Adverse events

Time frame: from enrollment until end of follow-up, 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NEUROMARK Treatment	0 of 36 (0%)	2 of 36 (5.6%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38835333Reh DD, Lay K, Davis G, Dubin MG, Yen DM, O'Malley EM, Sillers M. Long-term outcomes following impedance-controlled radiofrequency ablation for the treatment of chronic rhinitis. Laryngoscope Investig Otolaryngol. 2024 Jun 4;9(3):e1286. doi: 10.1002/lio2.1286. eCollection 2024 Jun.
Derived from this study: PubMed 37090860Reh DD, Lay K, Davis G, Dubin MG, Yen DM, O'Malley EM, Sillers M. Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis. Laryngoscope Investig Otolaryngol. 2023 Mar 16;8(2):367-372. doi: 10.1002/lio2.1040. eCollection 2023 Apr.
Individual participant dataSharing planned: No

Related trials for Chronic Rhinitis

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
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RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
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Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
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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

4 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 4 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 23 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 8 Jun 2026). 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 Device- or Procedure-related Serious Adverse Events (SAEs) Within 1 Month (time frame: 1 month). 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 NCT05324397, which also lists 2 linked publications.

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 Sep 2026.