NCT05110989招募中不适用
The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 11
- 主要终点
- Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management
研究概览
简要总结
This is a retrospective and prospective, multicenter, observational patient registry to record outcomes from patients undergoing cryoablation of the intercostal nerves (cryoanalgesia) for post-operative pain management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose age is 12 years or above, and are able to give informed consent/assent specific to state and national law.
- •Patients have been scheduled by physician(s) to undergo or have undergone cryoablation of the intercostal nerves utilizing at least one AtriCure device or are similar patients treated without the use of cryoablation
排除标准
- •Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
- •Patient with exclusion criteria required by local governance.
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study
结局指标
主要结局
Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management
时间窗: From enrollment to 5 years after date of index procedure
Collect pain score to assess the effect of cryoanalgesia effect with a follow up duration of up to 5 years.
Safety of cryo nerve block to generate cryoanalgesia as post operative pain management
时间窗: From enrollment to 5 years after date of index procedure
Collect adverse events occurred during and post operation to assess the safety of the cryo nerve block procedure.
次要结局
未报告次要终点
研究者
研究点 (11)
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