Overview
A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.
Eligibility
Inclusion Criteria:
- At least 18 years of age
- Having a BMI of at least 20 kg/m2
- Scheduled to undergo elective gynecological procedure
- 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 BMI higher than 60 kg/m2.
- Emergency procedures (e.g., ectopic pregnancy, severe bleeding).
- Significant comorbidities: e.g. cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
- Individuals with pacemakers, defibrillators, or other electromedical implants.
- Individuals with ferromagnetic implants.
- Clinical history of impaired coagulation confirmed by abnormal blood tests.
- 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.