NCT04740047已完成不适用
Cios Mobile 3D Spin for Robotic Bronchoscopy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Tool in Lesion
研究概览
简要总结
Evaluate the clinical utility and early performance of the Cios 3D Mobile Spin in conjunction with the Ion Endoluminal System, to visualize and facilitate the sampling of pulmonary nodules between 1-3 cm via the airway.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject age 18 years and older
- •Subject is suitable for elective bronchoscopy
- •Subject with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease
- •Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤3.5 cm in largest dimension
- •Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus)
- •Subject is a candidate for CT-guided needle biopsy
- •Subject is able to understand and adhere to study requirements
- •Subject is able to understand and adhere to study requirements and able to provide informed consent
- •Subject is not legally incapacitated or in legal/court ordered institution
- •Subject has no dependency on the investigator or sponsor
排除标准
- •Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure
- •Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure
- •Clinically relevant partial trachea obstruction or obstruction of vena cava per physician assessment
- •Acute respiratory failure, clinically significant hypoxemia, or high respiratory rate (i.e. > 30 breaths per minute) per physician assessment
- •Renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C)
- •World Health Organization functional Class IV Pulmonary Hypertension or history of clinically significant mPAP
- •Known or suspected pregnancy
- •Recent head injury (<12 weeks pre-procedure) or subjects presenting with clinically significant neurologic deficits
- •Unstable hemodynamic status (i.e. Dysrhythmia requiring intervention, altered mental status/consciousness)
- •Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 > 88% or requiring >4L of oxygen prior to procedure)
- •Subject with uncorrectable coagulopathy, bleeding or platelet disorders, history of major bleeding with bronchoscopy
- •Subjects contraindicated for intubation or general anesthesia, or subjects with ASA ≥ 5
- •Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e. heparin or warfarin) or /platelet aggression inhibitors (i.e. Abciximac or Eptifibatide) medications that cannot be stopped per standard practice, i.e. 5-7 days pre-procedure or heparin that cannot be held according to standard practice (6-12 hours). Aspirin not included.
- •Any severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy
- •Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician
- •Endobronchial lesion associated with lobar atelectasis
- •Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
- •Non-systemic treatment for lung cancer (i.e. SBRT) performed in the same lobe as the target nodule(s)
- •Previous surgical intervention performed in the same lobe as the target nodule (s)
结局指标
主要结局
Tool in Lesion
时间窗: At the time of the procedure
Ability to visualize on 3D imaging the pre-planned target location characterized when displayed distance of catheter tip to nearest edge of the virtual target is ≤ 2cm and is oriented towards the lesion in 3 axes.
次要结局
- Procedure-related complications(6 months)
- Duration-related outcomes(At the time of the procedure)
研究者
Janani S. Reisenauer
Principal Investigator
Mayo Clinic
研究点 (1)
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