A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgic… (NCT07293611) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
Chile30 participantsStarted 2026-03-30
Plain-language summary
A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
Who can participate
Age range
18 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:
* BMI range of 20 to 60kg/m2
* Scheduled to undergo laparoscopic procedures
* Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study- required procedures
Exclusion Criteria:
* Individuals with pacemakers, defibrillators, or other electromedical implants
* Individuals with ferromagnetic implants
* American Society of Anesthesiologists (ASA) score of III or IV
* Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
* Clinical history of impaired coagulation confirmed by abnormal blood tests
* Individuals who have signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.)
* Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
* Pregnant or wishes to become pregnant during the length of study participation
* Individual is not likely to comply with the follow-up evaluation schedule
* Participating in a clinical trial of another investigational drug or device
* Prisoner or under incarceration
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.
1Since this trial is actively enrolling but no longer recruiting new participants, is there any chance I could still be considered, or are there similar studies using magnetic surgical systems that I might be eligible for?
2This study is measuring the number of ports used during surgery — can you explain what that means for me practically, and whether using fewer ports could reduce my recovery time or scarring compared to standard laparoscopic surgery?
3Since this trial is categorized as 'Phase NA,' meaning it's focused on device safety and feasibility rather than proving a treatment benefit, what do we actually know so far about whether this magnetic system is safe to use in upper gastrointestinal surgeries?
4One of the main things being measured is the rate of device or procedure-related adverse events — what kinds of complications have been seen or are being watched for with this magnetic surgical system, and how does that compare to risks with conventional laparoscopic tools?
5Before considering a trial like this involving a newer surgical device, should I first explore whether a standard laparoscopic approach without the magnetic system would be the more established and safer option for my specific situation?
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.
What they're measuring
1
Number of Participants with Device and/or Procedure Related Adverse Events
Timeframe: From enrollment to end of follow up at 30 days.