DRKS00027559已完成1 期
Intraoperative Pancreatic Leakage Indicator – Post Market Confirmatory Study (PMCF, IDEAL Stage I) - ViP
Magle Chemoswed AB0 个研究点目标入组 30 人开始时间: 2022年3月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Planned partial pancreatectomy for any indication including minimally invasive and open distal pancreatectomy and partial pancreatoduodenectomy
- •2. Age = 18 years
- •3. Ability of subject to understand character and individual consequences of the clinical trial.
- •4. Willing and able to give written informed consent for participation in the investigation
排除标准
- •1. American Society of Anesthesiologists (ASA) Score > 3
- •2. Pregnancy or lactation
- •3. Allergy or known intolerability to bromothymol blue or potato starch
- •4. Participation in another interventional trial with interference of intervention or outcome of this study
- •5. Any condition which could result in an undue risk for the patient in the opinion of the investigator
- •6. Expected lack of compliance or language problems
研究者
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