NCT00962650已完成不适用
A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.
Ethicon Endo-Surgery2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Completion of Diagnostic Peritineoscopy
研究概览
简要总结
The study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women will be enrolled in this study who:
- •Are willing to give consent and comply with evaluation and treatment schedule;
- •At least 18 years of age;
- •Are a candidate for surgical weight loss intervention (i.e. meet ASMBS and NIH criteria) for an RYGB procedure at the Investigational site;
- •Have a history of open abdominal surgery or laparoscopic abdominal surgery;
- •ASA Classification I, II, or III (Appendix II); and
- •Have a negative serum pregnancy test (for women of childbearing potential).
排除标准
- •Subjects will be excluded from the study for any of the following:
- •Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
- •Acute cholecystitis or acute pancreatitis;
- •Evidence of abdominal abscess or mass;
- •Diffuse peritonitis;
- •Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;
- •Clinical diagnosis of sepsis;
- •Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
- •Planned concurrent surgical procedure other than RYGB or adhesiolysis;
- •Prior or planned major surgical procedure within 30 days before or after study procedure;
- •Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
- •Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or
- •Any condition which precludes compliance with the study (Investigator discretion).
结局指标
主要结局
Completion of Diagnostic Peritineoscopy
时间窗: Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar
Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome.
次要结局
未报告次要终点
研究者
研究点 (2)
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