NCT07318402招募中不适用
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 3
- 主要终点
- total operator radiation exposure dose
研究概览
简要总结
This is a multicenter, single-arm, prospective, observational study designed to evaluate bronchoscopist radiation exposure during standard-of-care image-guided robotic-assisted bronchoscopy (RAB) for sampling of a single pulmonary parenchymal lesion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Operator performing image-guided RAB on adult patients (age ≥18 years old)
- •A single participating operator per study site
- •Image-guided RAB procedure is planned for standard of care diagnostic sampling of a single parenchymal lung lesion at participating sites
排除标准
- •Operator refusal to participate
- •Image-guided RAB procedure performed on:
- •Patients age <18 years old
- •Pregnant women
- •Patients undergoing standard of care robotic assisted bronchoscopy with plan to sample >1 pulmonary parenchymal lesion
- •Patients undergoing standard of care robotic assisted bronchoscopy for lesion localization (injection of dye/marker or fiducial marker deployment)
- •Patients undergoing standard of care robotic assisted bronchoscopy for a therapeutic intervention
研究组 & 干预措施
Operator Radiation
During Image-Guided Robotic-Assisted Bronchoscopy
结局指标
主要结局
total operator radiation exposure dose
时间窗: 1 year
as captured by a radiation dosimetry badge over 50 consecutive procedures. All study procedures in which image-guided RAB was performed for the sampling of a single parenchymal lung lesion will be evaluable for the primary endpoint.
次要结局
未报告次要终点
研究者
研究点 (3)
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