NCT03893539进行中（未招募）不适用
PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 365
- 试验地点
- 12
- 主要终点
- Navigation Success
研究概览
简要总结
The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 aged 18 years and older
- •Patient is suitable for elective bronchoscopy
- •Patients 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 ≤ 3cm in largest dimension
- •Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus*
- •Patients are candidates for CT-guided needle biopsy and/or surgical resection
- •Patient able to understand and adhere to study requirements
- •Patient able to understand and adhere to study requirements and able to provide informed consent
- •Patient not legally incapacitated or in legal/court ordered institution
- •Patients with 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 III or Class IV Pulmonary Hypertension or history of clinically significant mPAP
- •Lung abscess
- •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)
- •Subjects with pure ground glass opacity target nodule
- •Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 > 92% 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 ≥ 4
- •Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e heparin or warfarin) or platelet aggression inhibitors (i.e. Abciximab 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 (i.e. >Stage 3 heart failure)
- •Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician
- •Endobronchial lesion associated with lobar atelectasis
- •Presence of bullae >1cm located within a cone based trajectory of biopsy instruments or in location presenting risk per physician assessment
- •Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
- •Subjects taking the following medications: Immunosuppressive treatment with systemic azathioprine, Cyclosporine, antibodies or cytostatics, other chemotherapeutic agents or medications acting on immunophilins
- •Non-systemic treatment for lung cancer (i.e. SBRT, ablation) performed in the same lobe as the target nodule(s)
- •Previous surgical intervention (i.e. wedge resection or lobectomy) within the same lobe as target nodule (s)
- •Participation in any interventional clinical study or clinical study with experimental agents or agents of unknown risk in last 30 days prior to screening
结局指标
主要结局
Navigation Success
时间窗: Day 1 (Time of Procedure)
Biopsy Success
时间窗: Day 1 (Time of Procedure)
Sensitivity for Malignancy of System-Obtained Sample
时间窗: 14 months Post-Procedure
次要结局
- Complications(Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure)
研究者
研究点 (12)
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