NEUROMARK Registry Study

Neurent Medical

Status: Active, not recruiting

Conditions: Chronic Rhinitis

Treatments: Device: NEUROMARK System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05937308

CIP-0008

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

NEUROMARK Treatment

Other group

Description:

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

Treatment:

Device: NEUROMARK System