跳至主要内容
临床试验/NCT00748124
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

Integra LifeSciences Corporation1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2008年8月1日最近更新:
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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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