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Completed
NCT07293611
A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
Conditions: Upper Gastrointestinal Laparoscopic Surgery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Levita Magnetics
Location: Clinica Colonial Huechuraba Santiago Metropolitan
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07293611). StuddyBuddy aggregates publicly available trial information.