3D Recording of a Trans-rectal Prostate Biopsy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Create 3D model of the prostate and accurately display the locations of the various biopsies taken during the procedure
研究概览
简要总结
Prostate biopsy is performed by multiple consecutive biopsy needle insertion into the prostate gland under a trans-rectal ultrasound probe guidance.
Today, the performing physician navigates the needle using a momentary 2D ultrasound image (longitudinal and transverse B mode) without any record of the full prostate boundaries or previous biopsies' location.
This study's Objectives are to record the trans-rectal biopsy procedure including the initial scan and the needle biopsy location and to modulate a 3D model of the prostate with accurate display the locations of the various biopsies taken during the procedure.
详细描述
3D record of a trans-rectal prostate biopsy
Clinical Study Protocol Study no: NaviGo -01
Sponsor: UC-CARE. Apollo Bld. 3rd fl. Hi-Tech Park P.O.Box 67 Yokneam 20692 Israel Tel: 972-4-9097427 Fax:972-4-9937323
Feb. 2011 Version: 02
ABBREVIATIONS:
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Planned for trans-rectal prostate biopsy
- •Signed informed consent
排除标准
- •Patient's unwilling to participate
- •Patients with metal prosthetics
结局指标
主要结局
Create 3D model of the prostate and accurately display the locations of the various biopsies taken during the procedure
时间窗: Post procedure ( off-line ) within a 3-5 working days
次要结局
未报告次要终点