Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline.
研究概览
简要总结
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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
研究组 & 干预措施
NOVOCLEAR™ Device Treatment Group
Subjects treated with pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.
干预措施: NOVOCLEAR™ Device (Device)
结局指标
主要结局
Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline.
时间窗: 90 days
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.
Proportion of subjects with device and/or procedure-related serious adverse events through 90 days
时间窗: 90 days
Characterization of the type and frequency of study device and/or study procedure-related adverse events reported during or following the study procedure through 90 days follow-up.
次要结局
- Mean change in rTNSS at 7 days compared to baseline(7 days)
- Mean change in rTNSS at 14 days compared to baseline(14 days)
- Mean change in rTNSS at 30 days compared to baseline(30 days)
- Mean change in rTNSS at 6 months compared to baseline(6 months)
- Mean change in rTNSS at 1 year compared to baseline(1 year)
- Mean procedure tolerability using a Visual Analogue Scale (VAS) at post-procedure(Post-procedure)
- Subject satisfaction at 90 days(90 days)