NCT00889928已完成不适用
A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy 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4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
- Procedure Completion
研究概览
简要总结
The study will document being able to successfully remove a subject's gallbladder through the vagina (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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women will be enrolled in this study who:
- •Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;
- •At least 18 years of age;
- •Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;
- •ASA Classification I or II (Appendix II);
- •Have a negative serum pregnancy test (for women of childbearing potential); and
- •Absence, on visual inspection, of adhesions judged to be a potentially complicating factor in transvaginal access and operation.
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);
- •Suspicion of gallbladder cancer, tumor, polyps, or mass;
- •Acute cholecystitis or acute pancreatitis;
- •Presence of common bile duct stones;
- •History of cervical or vaginal cancer (or precancerous findings on most recent Pap Test);
- •Pelvic Inflammatory Disease;
- •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;
- •History of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis;
- •History of peritoneal or vaginal trauma;
- •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;
- •Prior or planned major surgical procedure within 30 days before or after study procedure;
- •History of transvaginal surgery;
- •History of (or symptomatic for) abdominal adhesions;
- •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;
- •Any contraindication listed in a study device Instructions for Use (IFU) document (if that device may be used in the study procedure); or
- •Any condition which precludes compliance with the study (Investigator discretion).
结局指标
主要结局
Procedure Completion
时间窗: Day of Surgery
Completion of procedure - transvaginal removal of the gallbladder
次要结局
未报告次要终点
研究者
研究点 (2)
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