NEUROMARK Registry Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Rhinitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A Prospective, Multicenter, Single-arm, Post-market Interventional Registry. Collect real-world evidence.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NEUROMARK Treatment

Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System.

Group Type OTHER

NEUROMARK System

Intervention Type 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.

Interventions

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NEUROMARK System

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Subject MUST:

1. Be ≥18 years of age.
2. Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
3. 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.
4. Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No