NCT06042205进行中（未招募）不适用
ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Atraumatic Hernia Repair System (TAHRS) for Laparoscopic Hernia Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Tissium
- 入组人数
- 78
- 试验地点
- 8
- 主要终点
- Serious Adverse Device Effect (SADEs)
研究概览
简要总结
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years old or older;
- •Patient willing and able to provide a signed Patient Informed Consent Form;
- •Has a midline primary ventral, umbilical or incisional hernia;
- •Scheduled for a laparoscopic IPOM hernia repair;
- •Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect
排除标准
- •Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
- •Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
- •Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
- •Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
- •Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;
- •Patient has more than one hernia defect (to be confirmed intraoperatively);
结局指标
主要结局
Serious Adverse Device Effect (SADEs)
时间窗: through 12 months post-surgery
Cumulative incidence of complications (CIC) related to the TAHRS including: Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction,
次要结局
- Rate of hernia recurrence through 12 months post- surgery(through 12 months post-surgery)
研究者
研究点 (8)
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