Levita Magnetic Grasper Device Safety and Performance Study

Inclusion criteria

• 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

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