OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TransMedics
- 入组人数
- 79
- 试验地点
- 8
- 主要终点
- Patient and graft survival
研究概览
简要总结
Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.
详细描述
The purpose of this continuation study is to collect five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System. The EXPAND Lung trial results have been presented and have shown positive results in the use of expanded criteria donor lungs and patient follow-up, post-transplant. The current study is being conducted to continue to collect follow-up on participants in the EXPAND study, in order to evaluate long-term patient survival status and BOS diagnosis.
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
- •Registered male or female primary double lung transplant candidate
- •Age ≥18 years old
- •Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
排除标准
- •Prior solid organ or bone marrow transplant
- •Single lung recipient
- •Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
结局指标
主要结局
Patient and graft survival
时间窗: 5 years
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Presence or absence of bronchiolitis obliterans sydrome (BOS)
时间窗: 5 years
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
次要结局
未报告次要终点