NCT07197775Enrolling By Invitation不适用
Endogenex PULSE Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This registry is designed to collect long-term data and support ongoing post-market surveillance of real-world data for the Endogenex System.
详细描述
This is an observational registry that is designed to facilitate long-term patient follow-up for up to 5 years after an Endogenex procedure. It is structured to enable systematic longitudinal data collection on the safety and long-term clinical outcomes associated with the Endogenex System.
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
- •Type 2 diabetes
- •Have been treated with the Endogenex System
- •Consented to participate in the Endogenex PULSE Registry
排除标准
- •Unwilling or unable to attend study visits
- •Unwilling or unable to provide medical records to study sites
结局指标
主要结局
Incidence of adverse events
时间窗: Through 5 years
Incidence of device-related and/or procedure-related adverse events
次要结局
未报告次要终点
研究者
研究点 (4)
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