Benign Gallbladder Disease
Conditions
Brief summary
The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
Interventions
DEVICEUse of Levita Magnetics Grasper
Sponsors
Levita Magnetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment of AEs | During surgery | Absence of any damage or side effect to the patient directly produced by the device during the surgery |
| Feasibility of Mobilization | Intra-operative | Ability to adequately mobilize the organ during the surgery |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Use of Levita Magnetics Grasper Use of Levita Magnetics Grasper | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Use of Levita Magnetics Grasper |
|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 12.4 |
| BMI | 27.0 kg/m squared STANDARD_DEVIATION 3.6 |
| Indication for surgery Gallbladder polyps | 7 participants |
| Indication for surgery Gallbladder stones | 43 participants |
| Region of Enrollment Chile | 50 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 5 Participants |
| Ultrasound assessment of abdominal wall thickness | 2.6 cm STANDARD_DEVIATION 0.6 |
| Ultrasound assessment of gallbladder thickness | 1.8 mm STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 19 / 50 |
| serious Total, serious adverse events | 2 / 50 |
Outcome results
Primary
Feasibility of Mobilization
Ability to adequately mobilize the organ during the surgery
Time frame: Intra-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Use of Levita Magnetics Grasper | Feasibility of Mobilization | Organ adequately mobilized | 50 Participants |
| Use of Levita Magnetics Grasper | Feasibility of Mobilization | Excellent quality of exposure | 45 Participants |
| Use of Levita Magnetics Grasper | Feasibility of Mobilization | Sufficient quality of exposure | 5 Participants |
| Use of Levita Magnetics Grasper | Feasibility of Mobilization | Insufficient quality of exposure | 0 Participants |
Primary
Safety Assessment of AEs
Absence of any damage or side effect to the patient directly produced by the device during the surgery
Time frame: During surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Use of Levita Magnetics Grasper | Safety Assessment of AEs | No device related adverse events | 50 Participants |
| Use of Levita Magnetics Grasper | Safety Assessment of AEs | Device related adverse events | 0 Participants |