Electromagnetic Tracking of Devices During Biopsy Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Radiation Dose
研究概览
简要总结
The purpose of the trial is to evaluate the differences between PercuNav assisted and unassisted biopsy in the areas of CT radiation dose, procedure time and biopsy accuracy.
This prospective, randomized, controlled trial will compare the use of electromagnetic tracking and image guidance (CT) during biopsy procedures verses the typical CT image guided procedure alone.
详细描述
The purpose of the trial is to evaluate the differences between PercuNav assisted and unassisted biopsy. The primary objective of this study is to assess and quantify any differences between assisted and unassisted CT guided biopsy procedures of the liver with respect to radiation dose.
The secondary objectives of this study are to assess and quantify any differences between assisted and unassisted CT guided biopsy procedures with respect to:
- Total procedure time
- Accuracy of needle targeting (distance from defined target on PercuNav and angle of entry)
- Number of needle passes
- Target registration error (TRE- distance between "virtual" needle position (tracking data) and the actual needle position (CT confirmation scan))
The study will consist of 50 patients from 1 site. The expected completion time for enrollment is 3 months, but will depend on the ability of the clinic to enroll patients. There are two arms in the study. An Unassisted Biopsy Control arm (physician and patient blinded to needle positioning using PercuNav system) and Assisted Biopsy (Physician not blinded to needle positioning using PercuNav). Patients will be randomized to each arm.
The PercuNav provides real-time, three-dimensional visualization and navigation tools for all stages of diagnosis and surgery including pre-procedure planning and intra-procedure navigation. PercuNav transforms two-dimensional patient images (scan sets), derived from CT, PET/CT and MRI into dynamic representations on which a tool can be navigated and fused with ultrasound. The system performs spatial mapping from one image space to another image space or from image space to physical space (registration) allowing the physician to correlate scan sets with each other and to the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Has had a pre-operative CT scan performed and will be undergoing a biopsy procedure of the liver;
- •Is over the age of 18;
- •Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol;
- •Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.
排除标准
- •Was precluded from a biopsy procedure based on standard exclusions;
- •Has an adhesive allergy (due to the application of active fiducials with adhesive backing);
- •Has a pacemaker or automatic implantable cardiac defibrillator;
- •Has a gross body weight above 180lbs for women and 260lbs for men;
- •Is pregnant
- •A patient may be excluded after enrollment if any of the following criteria are met:
- •The patient's health and/or safety become jeopardized for any reason making it unsafe to continue;
- •Technical errors and/or difficulties;
- •Any reasonable rationale put forth by the physician or investigator
- •Lost to follow up - In-evaluable data
结局指标
主要结局
Radiation Dose
时间窗: 24 hrs
The primary objective of this study is to assess and quantify any differences between assisted and unassisted CT guided biopsy procedures of the liver with respect to radiation dose.
次要结局
- Total procedure time(24 hrs)
- Accuracy of needle targeting(24 hrs)