Post Market Study of the Flexagon Only System and Flexagon Plus OTOLoc for Creation of Side-to-Side Duodeno-Ileal Diversion & Flexagon Plus OTOLoc Self Forming Magnet (SFM) System for Creation of Side-to-Side Jejunum-Jejunum and Ileal-Ileal Anastomoses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
研究概览
简要总结
The objective of this study is to confirm the safety and effectiveness of the Flexagon & Flexagon Plus OTOLoc systems when used to create respective side-to-side anastomosis in participants undergoing laparoscopic / endoscopic small bowel surgery.
详细描述
This is a prospective, multicenter, single-arm post market study of 70 minimum treated patients.
Eligible patients requiring side-to-side duodeno-ileal, jejunum-jejunum & ileal-ileal anastomosis will be evaluated for participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>21 years of age, at the time of informed consent
- •Indicated for a side-to-side duodeno-ileal diversion, jejunum-jejunum or ileal-ileal anastomosis and no other concomitant surgical procedures (i.e. hiatal hernia repair, ventral hernia repair or gallbladder removal) planned in conjunction with SFM device placement
- •Willing and able to comply with the Registry procedures and provide written informed consent to participate in the post market study
排除标准
- •Participant does not provide informed consent to be enrolled and followed in the study
- •Participants for whom medical condition warrants use of device outside of indication for use
- •Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period.
研究组 & 干预措施
Duodeno-ileal diversion anastomosis
Small Bowel Anastomosis with Flexagon SFM Device
干预措施: Small Bowel Anastomosis (Device)
Jejunum-jejunum & ileal-ileal anastomosos
Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc
干预措施: Small Bowel Anastomosis (Device)
结局指标
主要结局
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
时间窗: 30 Days
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.
次要结局
未报告次要终点