Clinical trial NCT02049983: Levita Magnetic Grasper Device Safety and Performance Study
Official title: Levita Magnetic Grasper Device Safety and Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Gallbladder Disease
Lead sponsor: Levita Magnetics
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Safety Assessment of AEs
timeFrame: During surgery
measure: Feasibility of Mobilization
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Luis Tisne
state: Metropolitana
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
state: Metropolitana
city: Santiago
country: Chile
facility: Hospital Salvador
state: Metropolitana
Study officials:
References:
citation: Rivas H, Robles I, Riquelme F, Vivanco M, Jimenez J, Marinkovic B, Uribe M. Magnetic Surgery: Results From First Prospective Clinical Trial in 50 Patients. Ann Surg. 2018 Jan;267(1):88-93. doi: 10.1097/SLA.0000000000002045.