Levita Magnetic Grasper Device Safety and Performance Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Levita Magnetics
Sponsor:
Information provided by (Responsible Party):
Levita Magnetics
ClinicalTrials.gov Identifier:
NCT02049983
First received: January 28, 2014
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Benign Gallbladder Disease
Device: Use of Levita Magnetics Grasper

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Levita Magnetic Grasper Device Safety and Performance Study

Resource links provided by NLM:


Further study details as provided by Levita Magnetics:

Primary Outcome Measures:
  • Safety [ Time Frame: One month ] [ Designated as safety issue: Yes ]
    Absence of any damage or side effect to the patient directly produced by the device during the surgery

  • Feasibility [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
    Ability to adequately mobilize the organ during the surgery


Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Use of Levita Magnetics Grasper Device: Use of Levita Magnetics Grasper

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049983

Contacts
Contact: Amy Forrro (508) 254-1005 aforro@linceconsulting.com

Locations
Chile
Hospital Salvador Recruiting
Santiago, Chile
Contact: Ignacio Robles, MD         
Principal Investigator: Ignacio Robles, MD         
Hospital Padre Hurtado Recruiting
Santiago, Chile
Contact: Marcelo Vivanco, MD         
Principal Investigator: Marcelo Vivanco, MD         
Sponsors and Collaborators
Levita Magnetics
  More Information

No publications provided

Responsible Party: Levita Magnetics
ClinicalTrials.gov Identifier: NCT02049983     History of Changes
Other Study ID Numbers: LEV-TP-0010, Grant 13IEAT-20911
Study First Received: January 28, 2014
Last Updated: January 29, 2014
Health Authority: Chile: Institutional Review Board

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014