Levita Magnetic Grasper Device Safety and Performance Study (NCT02049983) | Clinical Trial Compass
CompletedNot Applicable
Levita Magnetic Grasper Device Safety and Performance Study
Chile50 participantsStarted 2014-01
Plain-language summary
The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.