NCT04953949已完成不适用
First-in-Human Trial of the Safety and Performance of NU-MAX® (IEIK13) as a Hemostatic Agent in Intracranial Neurosurgery
3-D Matrix Europe SAS2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年8月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- % of bleedings reaching hemostasis within 3 minutes
研究概览
简要总结
The objective of this clinical investigation is to determine the performance and safety profile of NU-MAX® when used as a topical hemostat for oozing bleedings encountered during intracranial procedures, in which control of bleeding by conventional hemostatic techniques is either ineffective or impractical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Have been informed on the nature of the clinical investigation and provided written informed consent, prior to initiation of any study activities.
- •Able and willing to comply with the clinical investigation follow-up schedule.
- •Male or female human subjects aged 18 years or older at time of enrollment.
- •Requiring hemostasis during elective intracranial procedures, in which the intradural space is accessed and where the control of bleeding by conventional hemostatic techniques is either ineffective or impractical.
- •NU-MAX® is used at least once intraoperatively.
排除标准
- •Patients undergoing emergency craniotomy for traumatic lesions or patients undergoing surgery for primary intracranial hemorrhage.
- •Patients undergoing surgical procedures using a transsphenoidal approach.
- •Intraoperative use of a different topical chemical hemostatic agent prior to the use of NU-MAX® during the same procedure and on the same bleeding point or in the same resection cavity.
- •Patients with a coagulation disorder or medical treatment affecting coagulation or platelet function, unless corrected or stopped prior to surgery.
- •Pregnant patients or patients planning to become pregnant during the clinical investigation.
- •Patients with known allergies to any of the components of NU-MAX®.
- •Patients currently participating in, or having been recently exited from (within 30 days from enrollment in this clinical investigation), or planning to enroll in another clinical investigation that may impact participation or outcomes (at the discretion of the sponsor) of this clinical investigation.
- •Patients with a condition, disorder, or other factor that, in the investigator's opinion, would interfere with study participation.
- •Fever (body temperature >38.5°C) prior to surgery, on the day of the procedure.
- •Patients with a Nickel allergy
结局指标
主要结局
% of bleedings reaching hemostasis within 3 minutes
时间窗: Intraoperatively
The percentage of bleedings reaching hemostasis within 3 minutes will be measured intraoperatively after the use of NU-MAX® (with a maximum of 3 measurements of hemostasis by NU-MAX® application per subject).
次要结局
- % of bleedings reaching hemostasis within 6 minutes(Intraoperatively)
研究者
研究点 (2)
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