NCT04712526撤回不适用
Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of reported device-related adverse events
研究概览
简要总结
The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.
详细描述
Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
- •Informed consent for study obtained and signed from each subject
排除标准
- •Planned open surgical approach
- •Use of staple line reinforcement material (buttress)
- •Revision or other bariatric procedure
- •Patients with a bleeding disorder: known coagulopathy, or Platelets <100,000, or PTT > 45sec, or PT> 15sec, or INR>1.5
- •Patients with active HIV or Hepatitis B
- •Patients under the age of 18 on the date of the surgery
- •Patients who are pregnant
- •Patients using tobacco products within the last 2 weeks prior to surgery date
- •Patients using cortisone or related products within the last 2 weeks prior to surgery date
结局指标
主要结局
Incidence of reported device-related adverse events
时间窗: Within 30-day post-operative period
次要结局
- Endoscopic staple line bleeding(Within surgery)
- Laparoscopic staple line bleeding(Within surgery)
- Incidence of intraoperative or postoperative blood transfusion(Within 72 hours of surgery start time)
- Incidence of product malfunction(Within surgery)
研究者
研究点 (1)
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