A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Preliminary Safety and Accuracy of the ActiSight Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Frequency of target reached within a radius of 5 mm from the preplanned targeted point as measured on the final CT scan
研究概览
简要总结
This study is designed to evaluate preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided lung aspiration or biopsy. This image guidance system uses a combination of CT scans and camera images to help guide a biopsy needle to a lung lesion. The system displays a simulated image of a biopsy needle and its estimated path for the biopsy.
详细描述
Why is this study conducted to demonstrate the safety and effectiveness of the ActiSight Needle Guidance System in assisting trained physicians perform CT guided percutaneous needle biopsy (PNB) and fine needle aspiration (FNA) procedures in the chest.
Subjects, who are scheduled for medically indicated chest PNB or FNA procedures and meet all the inclusion and exclusion criteria, will be asked to participate in the study. The aim is to enroll 40 subjects that will complete the whole study.
Recruited subjects will go through screening tests and if eligible, will undergo, within 18 days of screening, CT Guided chest PNB or FNA utilizing the ActiSight Needle Guidance system. Subjects will be observed and tested for at least an hour after the procedure to detect any serious complications. A follow-up will be conducted within 7-10 days after the procedure day for safety evaluations. Safety and accuracy data from all stages of the study will be collected and analyzed.
The effectiveness of the guidance system will be measured primarily by the frequency of reaching the intended targets, as determined by a final CT scan. Other measures will include the number of needle punctures and the number of intermediate CT scans needed to complete the procedure. The safety of the system will be measured by the frequency and severity of adverse events.
Procedure description:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Male or female subjects, 18 years of age or older at the time of enrollment
- •Subjects meeting all medical conditions for percutaneous chest aspiration/biopsy with safe path to lesion between ribs, however, not in the breast area in women or men with gynecomastia
- •Single target pulmonary lesion greater than 10 mm in size (diameter) and depth of lesion greater than 40 mm from the skin
- •Written informed consent to participate in the study
- •Ability to comply with the requirements of the study procedures
排除标准
- •Fibrous tissue or cyst in access path (not including target lesion)
- •Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
- •Use of ticlodipine or similar antithrombotic medication
- •For subjects taking warfarin or other anticoagulant medication, INR >1.3
- •Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
- •Patient is unable to comply with requirements of the procedure, i.e. holding breath
- •Participation in any prior investigational trial within 30 days of enrollment
- •Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition that could, in the opinion of the investigator, of interfering with the conduct of the study.
- •Subjects who are uncooperative or cannot follow instructions
结局指标
主要结局
Frequency of target reached within a radius of 5 mm from the preplanned targeted point as measured on the final CT scan
时间窗: Measure evaluated during entire course of study
次要结局
- Number of intermediate CT scans required to obtain sample(During entire course of study)
- Number of punctures required to obtain sample(Measure evaluated during entire course of study)
- An adequate sample obtained during the procedure(during entire course of study)