NCT06474637招募中不适用
Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post Operative Staple Line Complications
研究概览
简要总结
The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.
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
- •Be within the range of 18-65 years of age
- •Patients undergoing primary sleeve gastrectomy procedures
- •Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule.
排除标准
- •Prior bariatric surgery procedure
- •Sleeve gastrectomy procedure that is planned to be performed via open approach
- •Patients receiving anticoagulant medication(s)
- •Severe heart disease or lung problems
- •Known sensitivity to implant materials
- •Evidence of active (systemic or localized) infection at time of surgery
- •Women who are pregnant or planning to get pregnant in the next 12 months
- •Recent history of known alcohol and/or narcotic abuse
- •Investigational drug or device use within 30 days
- •Any other factors that may contribute, based on professional judgement of the treating surgeon, to the subject being a poor candidate for the study
结局指标
主要结局
Post Operative Staple Line Complications
时间窗: 1 week
The primary measure of effectiveness and safety will be determined by the incidence of post-operative staple line complications defined as requiring blood transfusion and revision surgery to treat staple line complications.
次要结局
- Hospital Stay(1 week)
- 36-Item Short Form Health Survey (SF-36)(3 weeks)
研究者
研究点 (1)
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