Multicentric, Prospective Clinical Study of Traumacel PULVIS Haemostatic Powder Application With or Without the Use of Traumacel ENDO Applicator in the Post-market Surveillance Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time required to achieve haemostasis
研究概览
简要总结
Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to prevent bleeding in the early post-operative stage, for example to stop capillary bleeding from resection areas of parenchymatous organs, muscles, to stop bleeding after endoscopy, mainly rectoscopic, procedures. The broadness of application allows for use in procedures performed in the standard way as well as endoscopically.
Traumacel ENDO Applicator is a single use, flexible, manual apparatus designed to deliver the absorbable haemostatic powder Traumacel PULVIS.
The main objective of this clinical study is to confirm the safety and efficacy of the medical device Traumacel PULVIS and Traumacel ENDO Applicator when used in accordance with their intended purpose.
The partial objectives are: to identify potential incompatibilities of Traumacel ENDO Applicator with other surgical instruments, in particular with different types of trocar cannulas; for both devices (Traumacel ENDO Applicator and Traumacel PULVIS) the identification and analysis of potential emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age of
- •Surgical intervention.
- •Negative pregnancy test of women in fertile age.
- •Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
- •Informed consent.
排除标准
- •Hypersensitivity or a known reaction to oxidized cellulose.
- •Age under 18
- •A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
- •The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
- •Pregnancy or lactation.
- •If during the procedure itself, there was no need to use the test agent
- •Application of any other topical haemostatic product prior to application of the test agent to the same site.
结局指标
主要结局
Time required to achieve haemostasis
时间窗: 10 minutes
Number of subjects who required a surgical revision within 12 hours after the procedure for recurrent bleeding
时间窗: 12 hours
Number of subjects in whom haemostasis was achieved within 3 minutes after administration
时间窗: 3 minutes
次要结局
- Occurrence of adverse events(1 month)
- Degree of bleeding from target bleeding site(10 minutes)