NCT06743620Enrolling By Invitation不适用
Prospective Observational Long-Term Safety and Effectiveness Registry of Patients Who Have Received Iltamiocel as Part of Cook Myosite, Inc. Sponsored CELLEBRATE Clinical Study in Patients With Persistent or Recurrent Stress Urinary Incontinence (SUI) Following Surgical Treatment
Cook MyoSite2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年4月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Long term safety
研究概览
简要总结
The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has completed participation within 15 months in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment (i.e., either subject has completed all follow-up visits or has been officially exited from the study).
- •Has received at least one dose of iltamiocel as part of the CLBT study.
- •Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.
- •Has access to a phone or electronic device to allow completion of electronic documents
排除标准
- •Has only received placebo as part of the CLBT study.
- •Unable or unwilling to provide informed consent.
结局指标
主要结局
Long term safety
时间窗: 5 years
Long term safety of iltamiocel
Long term effectiveness
时间窗: 5 years
Long term effectiveness of iltamiocel
次要结局
未报告次要终点
研究者
研究点 (2)
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