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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07293611). StuddyBuddy aggregates publicly available trial information.