Levita Magnetic Grasper Device Safety and Performance Study

Levita Magnetics

Status: Completed

Conditions: Benign Gallbladder Disease

Treatments: Device: Use of Levita Magnetics Grasper

Study type: Interventional

Funder types: Industry

Identifiers

NCT02049983

LEV-TP-0010

Grant 13IEAT-20911 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Use of Levita Magnetics Grasper

Experimental group

Treatment:

Device: Use of Levita Magnetics Grasper