A preliminary feasibility study to establish safety and efficacy of a Sinucare designed to perform balloon assisted sinus dilation (BSD) in Chronic Rhino sinusitis (CRS) Patients.
试验速览
- 阶段
- 1/2 期
- 状态
- Other
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary objectives of the study are to:
研究概览
简要总结
This feasibility study is designed to evaluate the safety and efficacy of a new medical device (Sinucare) for management of chronic rhinosinusitis. The intended use of Sinucare in final form is to perform minimally invasive sinus ostia dilation for patients suffering from chronic Rhinosinusitis. The system has a component (SinuGuide) that can attach to a standard rigid nasal endoscopy to facilitate the introduction of balloon catheters (SinuCath) inside sinus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients must be between 18 – 60 years of age (Both sexes).
- •â€¢Patients advised for a nasal endoscopy as part of standard of care.
- •â€¢Patient is hemodynamic stable with no bleeding disorders •Patient or a legal representative of the patient must be able to give written consent for the study.
排除标准
- •Patients on oral anti-coagulation.
- •Patients on inotropic drugs.
- •Patients with bleeding disorders like hemophilia.
- •Unwilling/ Unable to consent patients.
- •â€¢Patients with nasal polyposis •Enrolled in another interventional ENT clinical study •Grossly abnormal nasal anatomy that would not allow introduction of the Sinucare per doctor’s judgement.
- •Patients not co-operating with a standard endoscopic exam (excess movements, hysterics, needing restraints) Pregnant women.
结局指标
主要结局
The primary objectives of the study are to:
时间窗: The outcomes will be assessed at the end of each of the three phases of the study. Monitoring will be done for each patient to note any adverse events or issues with the study.
•To establish the feasibility of Sinucare for use during nasal endoscopy procedures
时间窗: The outcomes will be assessed at the end of each of the three phases of the study. Monitoring will be done for each patient to note any adverse events or issues with the study.
•To demonstrate the safety of Sinucare for use in patients undergoing rigid nasal endoscopic procedures
时间窗: The outcomes will be assessed at the end of each of the three phases of the study. Monitoring will be done for each patient to note any adverse events or issues with the study.
•To demonstrate the efficacy of SInucare in being used to dilate the sinus ostia of paranasal sinuses.
时间窗: The outcomes will be assessed at the end of each of the three phases of the study. Monitoring will be done for each patient to note any adverse events or issues with the study.
次要结局
- Secondary Outcomes(•Assess the Sinucare for the usability by a single clinician in an outpatient setting)