Levita Magnetic Grasper Device Safety and Performance Study
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Emergency presentation with acute gallbladder disease
Scleroatrophic gallbladder as shown by ultrasound
Biliary tract stones diagnosed before or during surgery
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