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

NCT05324397 | Completed FDA Device

• 1 other identifier: CIP-0006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Chronic Rhinitis

Keywords

Rhinitis

Outcome Measures

Primary Outcomes (2)

• Safety

  Safety will be evaluated based on frequency of Serious Adverse Events (SAEs) directly attributable to the NEUROMARK System at one (1) month post index procedure.

  1 month

• Efficacy

  Efficacy will be assessed by the change in Visual Analog Scale (VAS) Nasal Symptom Score (NSS) from baseline through 3 months for rhinorrhea and nasal congestion

  3 months

Study Arms (1)

Experimental: Treatment

EXPERIMENTAL

Subjects will undergo treatment with the NEUROMARK System

Device: NEUROMARK System

Interventions

NEUROMARK System DEVICE

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.

Experimental: Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Neurent Medical: lead

Study Sites (4)

Alabama Nasal and Sinus Center

Birmingham, Alabama, 35242, United States

Location

Centers for Advanced ENT Care

Baltimore, Maryland, 21204, United States

Location

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

Location

ENT & Allergy Associcates

Puyallup, Washington, 98374, United States

Location

Related Publications (2)

• 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.

  PMID: 38835333 DERIVED

• 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.

  PMID: 37090860 DERIVED

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Annalise Sorensen

  Neurent Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, single-arm, multicenter clinical study

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 12, 2022
• Study Start: March 14, 2022
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)