NCT06423690招募中不适用
Snipe Medical First In Human Study
Snipe Medical3 个研究点 分布在 3 个国家目标入组 15 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Safety of the EAS1 System in Lung Tumor Ablation During Procedure
研究概览
简要总结
A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor resection
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female subjects (age ≥18 years at the date of informed consent signature)
- •Subject is capable and willing to provide an informed consent
- •Subjects with a known diagnosis of lung cancer at cT1a-T1c, cN0 stages
- •At least one pulmonary tumor (primary or metastasis) ≤ 30 mm in maximal diameter, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening
- •Subjects who are scheduled or deemed eligible by a thoracic surgeon for lung tumor resection
- •Subject is able and willing to comply with the study procedures and visits
- •There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening
- •Stable doses of concomitant medications for at least four (4) weeks prior to enrollment
排除标准
- •An inability to provide informed consent
- •Subjects with contraindication for tumor resection
- •Subjects with life expectancy <12 months
- •Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
- •Subjects with Forced Expiratory Volume (FEV1) <50%
- •Total Lung Capacity (TLC)< 80% of expected for age
- •Diffusing Capacity (DCO) < 60% of expected
- •Oxygen saturation in free air of <88%, or requiring more than 2 l/min oxygen to achieve saturation of 92%
- •PCO2 of ≥ 45mm/Hg
- •Subjects in exacerbations group E (high risk; ≥2 exacerbations per year or ≥1 requiring hospitalization and any level of symptoms)
- •Severe emphysema, Bullous Emphysema or chronic obstructive pulmonary disease (COPD) (GOLD III/IV)
- •Active and/or prolonged lung or bronchi infection, required an antibiotic treatment up to 21 days prior to screening and for more than 10 days of treatment
- •Known history or current evidence of a significant bronchiectasis
- •Evidence of lung Bullae the occupies more than one third of the lung intended for ablation
- •Previous surgery in the lung intended for ablation; thoracic major surgery at the side intended for ablation
- •Anticoagulation treatment that cannot be discontinued prior to the ablation, or a bleeding diathesis or platelets <100 )K/µl)
- •Pregnant or breastfeeding female subjects or female subjects who plan pregnancy during participation in the study
- •Highly hypoxemic patients, according to investigator's discretion
- •Subjects with implanted metal or electronic thoracic devices objects (such as pacemaker) that cannot be removed prior to procedure
- •Subjects with contraindication for bronchoscopy
- •Participation in any other interventional clinical trial with medication, medical device and/or supplements within 30 days prior to informed consent signature
- •Any subject who, at the discretion of the investigator, may be jeopardized by study participation
结局指标
主要结局
Safety of the EAS1 System in Lung Tumor Ablation During Procedure
时间窗: 48 hours post procedure
Accumulative rate of device related Serious Adverse Events (SAEs) during the ablation and up to 48 hours post ablation
次要结局
- Safety of the EAS1 System in Lung Tumor Ablation Throughout Follow Up(30 days)
- Investigator's Ability to Approach and Ablate the Tumor (Technical Success)(30 days)
研究者
研究点 (3)
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