Feasibility Study of the Kronos Electrocautery Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Measure and Categorize Amount of Blood Loss From Biopsy Access Site
研究概览
简要总结
The primary objective for this study is to assess safety and performance of the Kronos Electrocautery Device for electrocautery procedures following coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc.
详细描述
The Kronos Electrocautery Device is intended to be used in electrocautery procedures to control bleeding by use of electrical current to heat the device probe tip that is applied directly to the target tissue area of treatment. Prospective, multi-center, single-arm study with consecutive, eligible subject enrollment at each site. Patients who require a coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc., will be eligible to participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing a scheduled, elective, coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc.,
- •Patients have signed an informed consent
- •Patients who are ≥ 18 years of age
排除标准
- •Patients with known bleeding disorder
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- •Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation.
- •Active illness or active systemic infection or sepsis.
结局指标
主要结局
Measure and Categorize Amount of Blood Loss From Biopsy Access Site
时间窗: 1 hour post procedure
The weight of 10 gauze pads is taken prior to the procedure. Post-procedure, those same 10 gauze pads used at biopsy access site are weighed again to measure in grams, the amount of blood loss. The scale ranges from 1 (unacceptable) to 5 (excellent).
Absence of Hematoma Formation
时间窗: 14 days
Patients will be contacted on day 14 post-procedure and asked a series of questions regarding Adverse Events related to the procedure.
Absence of the Need for Ultrasound Examination Due to Observation of Bleeding
时间窗: 8 hours post procedure
Measuring the amount of patient who did not need an ultrasound examination due to observation of bleeding
次要结局
- Absence of Secondary Reintervention(14 days)
- Time to Hospital Discharge(8 hours post procedure)