NCT00814450已完成不适用
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
ActiViews Ltd.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Frequency of target reached within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan.
研究概览
简要总结
This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.
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
- •INR <1.3
- •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
- •Central lesion is located in radius of less than 2 cm from lobar blood vessels and the heart.
- •The selected needle path has a safety margin of less than 2 cm from major blood vessels and the heart
- •Use of ticlopidine or similar antithrombotic medication
- •For subjects taking warfarin or other anticoagulant medication, INR >1.3
- •Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
- •Subjects who cannot tolerate mild sedation
- •Subjects with FEV1 < 800 mL unless approved by principal investigator following consultation with multidisciplinary team
- •Subjects with the following laboratory values, unless approved by hematologist:
- •Platelet count <100,000/mL
- •APTT >39 sec or PT >15 sec
- •Pregnancy or lactation
- •Patient is unable to comply with requirements of the procedure, i.e. holding breath
- •Participation in an 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 8 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 needle punctures through the skin(Measure evaluated during entire course of study)
- Number of needle punctures through the pleura(Measure evaluated during entire course of study)
- Number of CT scans needed(Measure evaluated during entire course of study)
- Radial distance at target plane at the needle's final position as shown on the ActiSight screen(Measure evaluated during entire course of study)
- Adverse events following the procedure, including the following:Pneumothorax, Hemoptysis >100 ml, Bleeding, Collapsed lung, Chest drainage, Need for hospitalization(Measure evaluated during entire course of study)
研究者
研究点 (2)
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