INJ-LIVERB-01 Identification of Liver Tumours Using BIP - Biopsy System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Difference in mean between measured bioimpedance spectra from tumorous and nontumorous tissue
研究概览
简要总结
This clinical device investigation is conducted by performing liver biopsies using the BIP - Biopsy Tool. The aim is to assess the feasibility of bioimpedance spectroscopy based biopsy tool guidance method and test how well BIP biopsy system is able to distinguish liver tumours from surrounding tissue. In addition, user feedback is obtained to improve the usability of the investigational device. The study does not affect the traditional treatment procedure and only the patients in clinical need for diagnosis by liver biopsy are included on voluntary basis. The invasive products used in actual biopsy operation are designed so that their performance is essentially equal to the currently used biopsy devices, the only difference is the measurement capability of biopsy needle and connection to measurement device.
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
- •Consenting adults undergoing ultrasound-guided core liver biopsy to diagnose liver tumour or other abnormalities
- •Identifiable non-tumorous liver tissue along the planned needle injection path.
排除标准
- •Inability to give informed consent
- •Being under aged
- •Being pregnant
- •Being high risk patient
- •Lack of identifiable non-tumorous liver tissue along the injection path to the tumour location
- •Known contraindications to liver biopsy.
研究组 & 干预措施
BIP Biopsy System
Biopsy system that enables real-time bioimpedance measurement from the tip of the biopsy needle.
干预措施: BIP Biopsy System (Device)
结局指标
主要结局
Difference in mean between measured bioimpedance spectra from tumorous and nontumorous tissue
时间窗: During liver biopsy (couple of minutes/patient)
Liver biopsy is performed in traditional way but with biopsy needle that enables bioimpedance measurement from multiple frequencies (spectrum). Tumorous and nontumorous tissue is measured during ultrasound guided biopsy procedure and the tumorous tissue type is verified by histological biopsy sample analysis. The bioimpedance spectra (impedance and phase angle) are compared with each other and differences in means of the spectra calculated. The data analysis is performed offline.
次要结局
未报告次要终点