Levita Magnetic Grasper Device Safety and Performance Study

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

Study Overview

• Status: Completed
• Conditions: Benign Gallbladder Disease
• Intervention / Treatment: Device: Use of Levita Magnetics Grasper

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Hospital Salvador
  • Santiago, Chile
    • Hospital Padre Hurtado
  • Santiago, Chile
    • Hospital Luis Tisne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of Levita Magnetics Grasper	Device: Use of Levita Magnetics Grasper

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Levita Magnetics

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 10, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases
• Other Study ID Numbers: LEV-TP-0010; Grant 13IEAT-20911 (Other Identifier: CORFO)