Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis

Обзор

Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis

Подробное описание

The NOVOCLEAR™ Device is a radiofrequency-based hand-held device intended to treat chronic rhinitis by delivering pulsed field energy to soft tissues in the nasal airway, including the posterior nasal nerve distribution. The NOVOCLEAR™ Device is used with the AVENTIX™ PFX System. The AVENTIX™ PFX System is a radiofrequency-based electrosurgical system designed to deliver non-thermal pulsed field energy to the targeted tissue.

This is a non-significant risk, prospective, multi-center, single arm study to evaluate the safety, effectiveness and tolerability of the NOVOCLEAR™ Device used with the AVENTIX™ PFX System.

Вмешательства

• Устройство NOVOCLEAR™ Device
  Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.

Первичные конечные точки

• Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline. [Срок оценки: 90 days]
• Proportion of subjects with device and/or procedure-related serious adverse events through 90 days [Срок оценки: 90 days]

Вторичные конечные точки (7)

• Mean change in rTNSS at 7 days compared to baseline [Срок оценки: 7 days]
• Mean change in rTNSS at 14 days compared to baseline [Срок оценки: 14 days]
• Mean change in rTNSS at 30 days compared to baseline [Срок оценки: 30 days]
• Mean change in rTNSS at 6 months compared to baseline [Срок оценки: 6 months]
• Mean change in rTNSS at 1 year compared to baseline [Срок оценки: 1 year]
• Mean procedure tolerability using a Visual Analogue Scale (VAS) at post-procedure [Срок оценки: Post-procedure]
• Subject satisfaction at 90 days [Срок оценки: 90 days]

Критерии участия

Критерии включения

• The subject is 18 to 85 years of age.
• The subject has had symptoms of chronic rhinitis for greater than 6 months with insufficient response to nasal steroids.
• The subject has an rTNSS total score of ≥ 6.
• The subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion (rTNSS rating of 2 or 3 for rhinorrhea and 1, 2, or 3 for congestion)
• The subject is able and willing to provide written informed consent and comply with the protocol requirements.

Критерии исключения

• The subject has clinically significant anatomic obstructions on either side that limit access to the posterior nose, including severe septal deviation, nasal polyps, and sinonasal tumor
• The subject has a septal perforation
• The subject has had prior sinus or nasal surgery on either side that significantly alters the anatomy of the posterior nose.
• The subject had had previous surgery of the PNN for chronic rhinitis.
• The subject has had prior head or neck irradiation
• The subject has an active or chronic nasal or sinus infection
• The subject has active coagulation disorder, or the patient is receiving anticoagulants
• The subject has a history of dry eye or dry nose symptoms
• Patient has rhinitis medicamentosa
• The subject has ocular allergic symptoms
• The subject has a history of nose bleeds
• The subject has electrically sensitive implants (e.g. cochlear implants, pacemakers, defibrillators)
• The subject is pregnant or lactating
• The subject is participating in another clinical research study
• The subject has an allergy or intolerance to anesthetic agent
• Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or pose an increased risk

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Colorado ENT and Allergy — Colorado Springs
• Bay Area ENT — Ocean Springs
• Atkins Expert Sinus Care — San Antonio

Идентификаторы

NCT: NCT06598319 · A2024-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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