VivAer: A Correlation Between Symptom Scores and Objective Findings
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- PNIF Measurement
研究概览
简要总结
This is a prospective, single-center study. This study seeks to determine the objective improvement in nasal airflow in patients after undergoing the VivAer procedure, which involves the use of a stylus to deliver controlled and targeted low energy radiofrequency heating (heating by applying high-frequency radio waves) to the nasal sidewall to gently reshape the tissues. Patients who experience refractory, or medically unexplained, nasal obstruction often have symptoms that are not alleviated or resolved by standard non-surgical treatment options. VivAer, a recently developed, FDA-approved procedure, is one of the standard surgical treatments for nasal obstruction. Unlike most of the other established surgical treatments for nasal obstruction, however, VivAer is a minimally-invasive procedure, and it is an outpatient intervention that can be performed under local anesthetic. Eligible patients who are enrolled in the study will undergo the VivAer procedure, and will return to the clinic for three in-office follow-up visits at 4, 12, and 24 weeks after the procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years and older seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
- •Nasal obstruction, defined as ≥60 by the NOSE scale.
- •The nasal valve is the primary or significant contributor to the subject's nasal obstruction as determined by the investigator, based on clinical presentation, physical examination, or nasal endoscopy.
- •Subjects has symptomatic improvement with use of external or internal nasal dilators, Q-Tip or curette test (manual intranasal lateralization), or the Cottle Maneuver (manual lateral retraction of the cheek).
- •Subject experienced minimal symptomatic improvement after the four-week fluticasone steroid nasal spray regimen.
排除标准
- •Prior surgery to the nasal valve, rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past 12 months.
- •Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy.
- •Severe case of any of the following; septal deviation, turbinate hypertrophy, polyps, or ptotic nasal tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention.
- •Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
- •Known or suspected pregnancy, or lactation.
- •Other medical conditions that the investigator believed would predispose subject to poor wound healing or increased surgical risk.
研究组 & 干预措施
VivAer Patients
These patients will undergo the VivAer procedure, which involves the use of a stylus to deliver radiofrequency heating to the nasal sidewall to reshape the tissue. This will be done to resolve the patients' nasal obstruction. They will have PNIF measurements taken and will complete symptom assessment questionnaires before and after the VivAer procedure.
干预措施: VivAer Stylus (Device)
结局指标
主要结局
PNIF Measurement
时间窗: This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.
The change in the severity of the patients' nasal obstruction will be measured using a Peak Nasal Inspiratory Flow (PNIF) meter. This meter measures nasal patency by measuring the volume of air that is inhaled per minute during normal breathing.
次要结局
- NOSE Score(This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.)
- SNOT-22 Score(This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.)
研究者
Auddie Sweis
Principal Investigator
Endeavor Health