jRCTs042240001进行中（未招募）不适用
Exploratory study of PuraStat (a novel self-assembling peptide) for hemorrhage during laparoscopic or robotic gastrectomy for Gastric cancer
未提供0 个研究点目标入组 20 人开始时间: 2024年5月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 主要终点
- -
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age at the time of consent is older than 18 years old
- •ECOG performance status (PS) is 0 or 1
- •Surgical treatment is scheduled within 2 weeks of obtaining consent
- •Planning to undergo laparoscopic or robotic gastrectomy for primary gastric cancer
- •Major organ functions are preserved
- •Written informed consent has been obtained
排除标准
- •(1) Patients with remnant gastric cancer
- •(2) Patients who have received preoperative chemotherapy
- •(3) Patients with a history of coagulation disorder
- •(4) Patients with psychiatric disorders that make it difficult to include in the study
- •(5) Patients receiving continuous systemic administration of steroid drugs or immunosuppressants
- •(6) Patients with a history of hypersensitivity to peptide or protein products
- •(7) Patients with a history of severe hypersensitivity
结局指标
主要结局
-
Percentage of hemostasis achieved in 3 minutes after PuraStat use
次要结局
未报告次要终点