Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures

Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures

A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.

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.