NCT05573048Enrolling By Invitation不适用
Optical Fusion Trans-Perineal Grid
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Needle placement accuracy
研究概览
简要总结
The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. The proceduralist can utilize this technology to find the best needle path to target within the pelvis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Scheduled for a MR guided biopsy or ablation.
- •One, two, or three tumor suspicious regions identified on multiparametric MRI.
- •Tolerance for anesthesia/sedation.
- •Ability to give informed consent.
排除标准
- •Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- •History of other primary non-skin malignancy within previous three years.
研究组 & 干预措施
Trans-Perineal Grid for prostate interventions
Experimental
Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure.
干预措施: Trans-Perineal Grid (Device)
结局指标
主要结局
Needle placement accuracy
时间窗: Baseline
Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and
次要结局
未报告次要终点
研究者
David A. Woodrum
Principal Investigator
Mayo Clinic
研究点 (1)
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