NCT02049983已完成不适用
Levita Magnetic Grasper Device Safety and Performance Study
Levita Magnetics6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年1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
- 50
- 试验地点
- 6
- 主要终点
- Safety Assessment of AEs
研究概览
简要总结
The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 60 years of age
- •Undergoing elective cholecystectomy due to:
- •Cholelithiasis (Gallbladder stones < 2.5cm in longer measurement (length or width))
- •Gallbladder polyps as assessed by ultrasound
- •Absence of non-correctable coagulopathy (INR < 1.4 or, platelet count of < 50,000/mcl)
- •Patient has a body mass index (BMI) ≤ 35 kg/m2 and over 20
- •Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure
排除标准
- •Emergency presentation with acute gallbladder disease
- •Pancreatitis
- •Scleroatrophic gallbladder as shown by ultrasound
- •Biliary tract stones diagnosed before or during surgery
- •Acute cholecystitis
- •Gallbladder Empyema
- •Ongoing peritoneal dialysis
- •Previous abdominal surgery or laparotomy (presence of any previous upper umbilical incision)
- •Presence of umbilical hernia or previous umbilical hernia
- •American Society of Anesthesiologists (ASA) score of III or IV
- •Patient is undergoing treatment for chronic pain of any origin
- •Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
- •Patients with signs of gallbladder perforation diagnosed by ultrasound
- •Suspicion of biliary cancer
- •Patients with severe peritonitis
- •Contraindications to pneumoperitoneum
- •Known allergy to paracetamol or NSAIDs
- •Patients with metallic implants (such as pacemakers, prosthesis, etc)
- •Previously diagnosed or suspected of having a history of choledocholithiasis based on any alterations in plasma hepatic enzymes
- •Has a biliary tract > 7mm in size as determined by ultrasound
- •Has a gallbladder wall thickness that is > 5mm
- •Diabetic Blood coagulation issues
- •Has signs of hepatic endocrinology (i.e: cirrhosis, liver failure, increase in liver enzymes, etc.)
- •History of endoscopic papillotomy (i.e: Preoperative indication of endoscopic retrograde cholangiopancreatography (ERCP)
- •Patient is pregnant or wishes to become pregnant during the length of study participation or lactation
- •Patient is not likely to comply with the follow-up evaluation schedule
- •Patient is participating in a clinical trial of another investigational drug or device
- •Patient is mentally incompetent or a prisoner
- •Known or suspected drug or alcohol abuse
- •Patient has systemic infection or evidence of any surgical site infection (superficial or organ space)
- •Patient has compromised immune system or autoimmune disease (WBC < 4000 or > 20,000), including prior or pending treatment for HIV or Hep. C
- •Patient intra-operatively needs an additional surgery while undergoing elective cholecystectomy
结局指标
主要结局
Safety Assessment of AEs
时间窗: During surgery
Absence of any damage or side effect to the patient directly produced by the device during the surgery
Feasibility of Mobilization
时间窗: Intra-operative
Ability to adequately mobilize the organ during the surgery
次要结局
未报告次要终点
研究者
研究点 (6)
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