Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- Safety of the Titan SGS stapler
研究概览
简要总结
The Titan SGS stapler is the first minimally invasive stapler designed for the longitudinal resection of the stomach. This is the first experience using this stapler in humans. The purpose of this study is to demonstrate use of the Titan SGS stapler in creating longitudinal gastric resection. Safety is defined by the absence of device related adverse events in the study period. Usability is evaluated based on surgeon evaluation of the device following each use.
This is a open label clinical trial to be conducted at three US sites. Up to 60 participants will be enrolled and will be followed for 6 weeks after surgery.
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
- •Patients age 18 to 65 undergoing a procedure requiring longitudinal gastric resection including: laparoscopic sleeve gastrectomy, laparoscopic gastric wedge resection, laparoscopic duodenal switch/loop duodenal switch.
排除标准
- •Age < 18 years
- •Incarceration
- •Prior gastric or foregut surgery (hiatal hernia repair, lap band +/- removal, Nissen fundoplication, gastrostomy tube, greater curve plication, sleeve gastrectomy etc.)
- •Diagnosed bleeding disorder (hyper or hypocoagulable state)
- •Systemic anticoagulation
- •Significant organ system disease
- •Stage III CKD or greater
- •Liver cirrhosis (any)
- •CHG with EF < 50%
- •COPD with O2 dependence
- •Uncontrolled diabetes mellitus (A1C > 10%)
- •Intraoperative surgeon evaluation indicates the subject is not a candidate for longitudinal gastric resection with the Titan Stapler due to anatomic factors such as extensive abdominal adhesions or the device will not fit for the particular application.
结局指标
主要结局
Safety of the Titan SGS stapler
时间窗: 6 weeks
• Safety will be defined using descriptive statistics for device related adverse events in the study period.
Usability
时间窗: 1 day
• Usability of the Titan SGS to resect the stomach will be determined by the intraoperative assessment of the surgeon. The surgeon will complete a questionnaire with assessments of the device.
次要结局
未报告次要终点