NCT06282094招募中不适用
ViSiGi LUX Bariatric Sizing and Calibration System Usability Study
Boehringer Labs LLC1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Physician Feedback
研究概览
简要总结
This study investigates the new ViSiGi LUX.
详细描述
ViSiGi is used during numerous gastric and bariatric procedures. The new device, ViSiGi LUX functions as the FDA-cleared ViSiGi but has the added visualization of NIR lights.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •able to consent
- •candidate for robotic bariatric surgery
排除标准
- •esophageal stricture that does not allow passage of the device
- •conditions that would preclude gastric or bariatric surgical procedures
- •pregnant patients
结局指标
主要结局
Physician Feedback
时间窗: 6 months
The physician provides feedback and comments on the usability of the device. The physician will rate the device on a Likert scale. 1-7 higher score is better
次要结局
未报告次要终点
研究者
研究点 (1)
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