NCT00720642已完成不适用
Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.
Intact Medical Corporation24 个研究点 分布在 1 个国家目标入组 1,170 人开始时间: 2006年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,170
- 试验地点
- 24
- 主要终点
- The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision.
研究概览
简要总结
To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient must be a female at least 18 years of age at the time of Intact BLES biopsy
- •Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis
排除标准
- •Patients who have pre-pectoral breast implants
- •Patients who have implantable devices such as pacemakers and defibrillators
- •Patients who are pregnant or lactating
- •Patients in whom the device is contraindicated
- •Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection
结局指标
主要结局
The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision.
时间窗: Post Intact Excision
次要结局
未报告次要终点
研究者
研究点 (24)
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