NCT02582944已完成1 期
Electromagnetic Navigation for Peripheral Pulmonary Lesions Using a Tip Tracked Steerable Catheter and Optical Guidance
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Diagnostic yield of peripheral bronchoscopy using the tip tracked steerable catheter with removable optics and electromagnetic navigation guidance
研究概览
简要总结
Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. The potential advantages of catheter based techniques include the ability to utilize instruments smaller than the diameter of a conventional bronchoscope, thereby allowing better access to the lung periphery. The drawbacks of a catheter based approach include the relative inability to steer a conventional catheter, and the inability to perform direct visualization and airway inspection through a conventional catheter. This study will evaluate a novel steerable catheter system with optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy peripheral pulmonary lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients with peripheral lung lesions 1-7cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
- •Are at least 18 years old
- •Are able to provide informed consent
排除标准
- •Patients who refuse to participate
- •Are less than 18 years of age
- •Are pregnant
- •Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
- •Are unable to provide informed consent
研究组 & 干预措施
Arm 1: Electromagnetic navigation
Experimental
- The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed.
- Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree.
- Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation.
- Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles.
干预措施: Olympus BF-180 bronchoscope (standard adult) (Device)
Arm 1: Electromagnetic navigation
Experimental
- The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed.
- Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree.
- Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation.
- Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles.
干预措施: Veran Spinview Thoracic Navigation System (Device)
Arm 1: Electromagnetic navigation
Experimental
- The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed.
- Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree.
- Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation.
- Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles.
干预措施: Olympus UM-S20-17S (Device)
Arm 1: Electromagnetic navigation
Experimental
- The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed.
- Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree.
- Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation.
- Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles.
干预措施: Biopsy (Procedure)
结局指标
主要结局
Diagnostic yield of peripheral bronchoscopy using the tip tracked steerable catheter with removable optics and electromagnetic navigation guidance
时间窗: At the time of procedure (1 day)
-Primary outcome of diagnostic yield based on final cytology and/or histopathology will be determined from the results of the bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, that adequately explains the clinical scenario as determined by the treating physician, will be considered truly positive.
次要结局
- Safety as measured by adverse event rates(At the time of procedure (1 day))
- Confirmation of successful navigation by using radial probe endobronchial ultrasound(At the time of procedure (1 day))
研究者
研究点 (1)
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