A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
研究概览
简要总结
This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm undergoing CT-guided percutaneous chest aspiration.
Target location will be in the chest area; the procedure will be performed by a trained physician.
详细描述
Subjects who are scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures will be screened for inclusion in the study.
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous chest aspiration or percutaneous biopsy utilizing the ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after the chest aspiration to detect the majority of post procedure pneumothoraces. A follow-up visit will be conducted within 7-10 days after the procedure day for safety evaluations.
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 —（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 scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures
- •Subjects with lung lesions less than 15 mm.
- •Written informed consent to participate in the study
- •Ability to comply with the requirements of the study procedures
排除标准
- •Subjects who cannot tolerate mild sedation
- •Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- •Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study.
- •Subjects who are uncooperative or cannot follow instructions
结局指标
主要结局
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
时间窗: 6 month
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
次要结局
- Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images(6 month)
- Number of needle punctures through the skin(6 month)
- Number of needle punctures through the pleura(6 month)
- Number of CT scans needed(6 month)
- Duration of procedure: patient preparation, planning, guidance and Cytolog report.(6 month)