Levita Magnetic Grasper Device Safety and Performance Study

Study Overview
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Brief Summary
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The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.

Official Title
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Levita Magnetic Grasper Device Safety and Performance Study

Conditions
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Benign Gallbladder Disease

Intervention / Treatment
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* Device: Use of Levita Magnetics Grasper


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of Levita Magnetics Grasper<br> | Device: Use of Levita Magnetics Grasper<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Absence of any damage or side effect to the patient directly produced by the device during the surgery | One month | 
| Feasibility | Ability to adequately mobilize the organ during the surgery | Intra-operative |