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 range18 Years
SexALL
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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
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.