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临床试验/NCT04398537
NCT04398537已完成不适用

The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2020年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
245
试验地点
2
主要终点
Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.

研究概览

简要总结

This will be a single-center prospective randomized control trial that is Institutional Review Board (IRB) approved. The study plans to enroll 250 female patients presenting to the University of Alabama at Birmingham (UAB) for stereotactic biopsy. This study is a prospective and will target approximately 250 patients. This will be a HIPPA-compliant randomized control trial planned on spanning approximately six months' time. Patients will be entered into the study only based on their already scheduled stereotactic biopsy procedure. Patients will be informed of the study and they will be offered the opportunity to participate or not participate in the study. Their participation is completely voluntary. This study will not involve any intervention that is not already a part of standard care. Patients will be randomized to two groups, one group that will undergo clip placement with approximately with a 5 mm retraction of the biopsy clip post-placement and one that will involve no retraction prior to deployment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Females 18-99 of age with recommendation for stereotactic biopsy.

排除标准

  • Non-female patients
  • Patients < 18 years old
  • Women who are pregnant

结局指标

主要结局

Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.

时间窗: baseline through 1 hour (post biopsy mammogram/procedure)

Average Distance of Clip Migration for the Arm That Received 5mm Retraction.

时间窗: baseline through 1 hour (post biopsy mammogram/procedure)

Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.

时间窗: baseline through 1 hour (post biopsy mammogram/procedure)

This number of participants will be counted if their clip migrated more than 10mm from the biopsy site.

Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.

时间窗: baseline through 1 hour (post biopsy mammogram/procedure)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefanie A. Woodard

Assistant Program Director, Diagnostic Radiology Residency Program Assistant Professor, Breast Imaging Section

University of Alabama at Birmingham

研究点 (2)

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