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New device zaps nose nerves to stop runny nose

NCT ID NCT05324397

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tested a device called NEUROMARK that uses radiofrequency energy to disrupt nerves in the nose. It included 36 adults with moderate to severe chronic rhinitis. The goal was to see if the procedure safely reduces symptoms like runny nose and congestion over 3 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NEUROMARK System (device that uses radiofrequency to disrupt posterior nasal nerves)
What this could lead to
If it works, this could offer a non-drug option to reduce chronic rhinitis symptoms like runny nose and congestion.
What could go wrong
This was a small, single-arm study with no placebo group, so results may not be definitive. There is a risk of side effects from the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Mar 2022

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). * 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). Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Alabama Nasal and Sinus Center

    Birmingham, Alabama, 35242, United States

  • Centers for Advanced ENT Care

    Baltimore, Maryland, 21204, United States

  • ENT & Allergy Associcates

    Puyallup, Washington, 98374, United States

  • Specialty Physician Associates

    Bethlehem, Pennsylvania, 18017, United States

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