NCT00748124终止3 期
A Prospective Multicenter Randomized Clinical Study to Evaluate the PleuraSeal Sealant System as an Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.
研究概览
简要总结
To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. surgical staples or sutures) will be compared to conventional surgical techniques alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy
排除标准
- 未提供
研究组 & 干预措施
PleuraSeal Sealant Device
Experimental
干预措施: PleuraSeal Sealant System (Device)
PleuraSeal Sealant Device
Experimental
干预措施: Standard Tissue Closure Techniques (Procedure)
Control
Other
干预措施: Standard Tissue Closure Techniques (Procedure)
结局指标
主要结局
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.
时间窗: 75 days
次要结局
未报告次要终点
研究者
研究点 (1)
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