Multicentre, Prospective, Post Market Observational Registry Study to Observe the Performance and Safety of the StypCel™ Device to Achieve Hemostasis During Neurosurgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MDCECRO LLC
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Time to Hemostasis
研究概览
简要总结
This study is a post-market clinical follow-up (PMCF) plan for the StypCel™ Absorbable Hemostat, a medical device used to control bleeding during neurosurgery. The study will monitor the device's safety and effectiveness in real-world conditions across multiple sites. It will include 108 patients who require the device during neurosurgery and will observe the time it takes to achieve hemostasis and track any complications, including infections and other serious adverse events. The study aims to ensure the continued safety and effectiveness of the device after it has been introduced to the market.
详细描述
The StypCel™ Absorbable Hemostat is designed to control bleeding during neurosurgical procedures. This PMCF study is an observational, multicenter investigation that will include 108 patients across up to 8 medical sites. The study's primary goal is to evaluate the device's ability to achieve hemostasis within 5 minutes during surgery. Secondary objectives include monitoring the rate of intracranial infections and other serious adverse events over 6 months. The study will help to confirm the safety and performance of the StypCel™ device in everyday clinical use and ensure it meets the required standards for patient safety. Data from the study will be collected at two-time points: 10 days and 180 days after the surgery, with follow-up assessments to monitor any delayed complications.
These summaries are written in plain language, ensuring they are accessible to non-specialists while still providing essential information about the study's objectives, methodology, and expected outcomes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18-75 years of age
- •Patients requiring a hemostat device during neurosurgery.
- •Patients and/or guardians agree to take part in the PMCF study and sign the Informed Consent Form.
排除标准
- •Patients with bone defects, because it may interfere with callus formation and a possibility of cyst formation.
- •StypCel™ should not be used in the control of hemorrhage from large arteries.
- •StypCel™ should not be used as an anti-adhesion product.
- •StypCel™ should not be used on the surface of non-hemorrhagic serous effusion, because in addition to the whole blood, the fluid does not react with the absorbable hemostat with satisfied hemostatic effect.
- •StypCel™ is to be avoided in surgical cases requiring stuffing and packing (as is sometimes medically necessary). It may only be used in such a situation if the surgeon completely removes the device after hemostasis is achieved.
结局指标
主要结局
Time to Hemostasis
时间窗: During surgery (typically within 5 minutes)
The primary outcome is the time taken to achieve complete hemostasis at the surgical site after applying the StypCel™ Absorbable Hemostat during neurosurgery. Hemostasis is defined as the cessation of bleeding without the need for additional interventions.
次要结局
- Rate of Serious Adverse Events(6 months post-surgery)
- Rate of Intracranial Infections(10 days and 6 months post-surgery)