Levita Magnetic Grasper Device Safety and Performance Study

Exclusion Criteria

• •Emergency presentation with acute gallbladder disease
• •* Pancreatitis
• •* Jaundice
• •* 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