NCT06934486尚未招募不适用
A Multi-Centre Prospective, Non-Comparative, Open, Post-Marketing Surveillance Study to Obtain Clinical Outcome Data on the Use of Tissue Patch in the Prevention of Air Leaks Following Lung Resection
C. R. Bard0 个研究点目标入组 250 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- Intra-operative air leaks
研究概览
简要总结
Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.
详细描述
Post-market study conducted to assess the continuing effectiveness and safety of TissuePatch SF when used as an adjunct to standard suture/staple closure of clinically significant (Macchiarini Grade ≥1) intra-operative visceral pleural air leaks incurred during lobectomy and segmentectomy (open or minimally invasive), including those performed as video-assisted thoracic surgery (VATS), in adults.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is ≥18 and <80 years of age
- •Undergoing planned (not emergent) video-assisted thoracic surgery pulmonary resection
- •Understands and is willing to comply with all study related procedures
- •Has provided signed informed consent
排除标准
- •Women who are pregnant or lactating or, if of childbearing potential, are unwilling to use birth control for 6-months following surgery
- •Has severe congestive heart failure, pulmonary or renal failure, serious haematological disorder or significant liver disease
- •Has previously undergone a pneumonectomy
- •Has a bronchial fistula
- •Has or is suspected of having an active infection at or near the planned surgical site
- •Has a known allergy or sensitization to TissuePatch SF or its constituent components
- •In the investigator's opinion, has a life expectancy of less than 12 months
- •Has, in the investigator's opinion, any disease or condition, physical or psychological, that could interfere with the evaluation of TissuePatch SF or compliance with study procedures
- •Intra-Operative Exclusion Criteria:
- •>3 identified air leaks
- •No air leaks Macchiarini Grade ≥1
研究组 & 干预措施
Patients with intra-operative air leak detected during lung resection
干预措施: TissuePatch Sealant Film (Device)
结局指标
主要结局
Intra-operative air leaks
时间窗: Prior to the completion of surgery
Air leaks successfully sealed or reduced as assessed by a submersion air leak test
次要结局
- Overall device safety(3-months post surgery)
- Overall device safety(6-months post-surgery)
研究者
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