Trial record 9 of 73 for:    Open Studies | "Gallbladder Diseases"

Levita Magnetic Grasper Device Safety and Performance Study

This study is currently recruiting participants.
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
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 April 14, 2014