Levita Magnetic Grasper Device Safety and Performance Study (NCT02049983) | Clinical Trial Compass
CompletedNot Applicable
Levita Magnetic Grasper Device Safety and Performance Study
Chile50 participantsStarted 2014-01
Plain-language summary
The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …