Levita Magnetic Grasper Device Safety and Performance Study

Benign Gallbladder Disease Clinical Trial

Official title:

Levita Magnetic Grasper Device Safety and Performance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049983
• Other study ID #: LEV-TP-0010
• Secondary ID: Grant 13IEAT-209
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: March 10, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Levita Magnetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Gallbladder Disease
• Gallbladder Diseases

Intervention

Device:
• Use of Levita Magnetics Grasper

Locations

Country	Name	City	State
Chile	Hospital Luis Tisne	Santiago
Chile	Hospital Padre Hurtado	Santiago
Chile	Hospital Salvador	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Levita Magnetics

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Absence of any damage or side effect to the patient directly produced by the device during the surgery	One month	Yes
Primary	Feasibility	Ability to adequately mobilize the organ during the surgery	Intra-operative	No